Port & Catheter, Implanted, Subcutaneous, Intravascular

FDA product code LJT · 282 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5965
Review panel: HO
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-01-12 – 2026-06-17

LJT 1991-04-19

STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED

Applicant Strato Medical Corp.

K number K905841

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LJT 1991-04-19

STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED

Applicant Strato Medical Corp.

K number K905840

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LJT 1991-04-19

STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED

Applicant Strato Medical Corp.

K number K905839

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LJT 1991-04-19

STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED

Applicant Strato Medical Corp.

K number K905838

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LJT 1991-04-15

LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015

Applicant Strato Medical Corp.

K number K911355

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LJT 1991-04-08

LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI

Applicant Strato Medical Corp.

K number K905848

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LJT 1991-04-08

STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION

Applicant Strato Medical Corp.

K number K905846

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LJT 1991-04-05

STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED

Applicant Strato Medical Corp.

K number K905851

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LJT 1991-04-05

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION

Applicant Strato Medical Corp.

K number K905847

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LJT 1991-04-03

STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED

Applicant Strato Medical Corp.

K number K905844

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LJT 1991-03-27

OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY

Applicant Norfolk Medical

K number K905646

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LJT 1991-03-13

VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM

Applicant Med Institute, Inc.

K number K910005

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LJT 1990-12-05

CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Device Labs, Inc.

K number K904417

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LJT 1990-10-31

GERARD MEDICAL, INC. TRIM-PORT

Applicant Gerard Medical Enterprises, Inc.

K number K903364

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LJT 1990-10-17

VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM

Applicant Med Institute, Inc.

K number K904077

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LJT 1990-10-12

A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.

Applicant Therex Corp.

K number K903691

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LJT 1990-10-10

PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Pharmacia Deltec, Inc.

K number K903220

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LJT 1990-09-05

DUAL PORT

Applicant Infusaid Corp.

K number K901419

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LJT 1990-07-03

CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Device Labs, Inc.

K number K901722

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LJT 1990-04-17

LIFE-LINE(TM) VASCULAR ACCESS SYSTEM

Applicant Medical Engineering and Development Institute

K number K895030

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LJT 1990-03-12

Q-PORT SYSTEM KIT

Applicant Quinton, Inc.

K number K894650

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LJT 1989-12-27

LIFEPORT VASCULAR ACCESS PORT

Applicant Strato Medical Corp.

K number K895689

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LJT 1989-12-06

A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT

Applicant Therex Corp.

K number K896093

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LJT 1989-11-17

LIFEPORT POLYURETHANE CATHETER

Applicant Strato Medical Corp.

K number K895871

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LJT 1989-06-23

A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM

Applicant Therex Corp.

K number K893460

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LJT 1989-06-12

MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.

Applicant Medtronic Versaflex, Inc.

K number K891611

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LJT 1989-04-21

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM

Applicant Harbor Medical Devices, Inc.

K number K890518

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LJT 1988-08-09

IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Burron Medical, Inc.

K number K881342

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LJT 1988-07-29

A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED

Applicant Therex Corp.

K number K882230

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LJT 1988-06-09

S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM

Applicant Harbor Medical Devices, Inc.

K number K882190

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LJT 1988-06-03

LIFEPORT II, MODEL LPS-1100

Applicant Strato Medical Corp.

K number K881075

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LJT 1988-05-11

INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER

Applicant Shiley Infusaid, Inc.

K number K881745

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LJT 1988-04-26

LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.

Applicant Strato Medical Corp.

K number K880305

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LJT 1988-04-21

NON CORING INFUSION SET

Applicant Taris Corp.

K number K881256

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LJT 1988-04-13

PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Pharmacia Deltec, Inc.

K number K875276

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LJT 1988-03-04

CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM

Applicant Catheter Technology Corp.

K number K880571

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LJT 1988-03-03

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE

Applicant Titan Medical, Inc.

K number K875213

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LJT 1988-02-19

SEA - PORT INFUSION SET

Applicant Harbor Medical Devices, Inc.

K number K880297

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LJT 1988-02-19

A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM

Applicant Therex Corp.

K number K875214

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LJT 1987-12-30

CHEMO-PORT

Applicant Hdc Corp.

K number K874184

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LJT 1987-11-13

UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90

Applicant Healthcare Technologies, Inc.

K number K873575

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LJT 1987-11-13

INFUSE-A-PORT ADDITIONAL SIZES

Applicant Shiley Infusaid, Inc.

K number K872329

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LJT 1987-11-03

MEDTRONIC CATHETER ACCESS PORT MODEL 8500

Applicant Medtronic Vascular

K number K873735

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LJT 1987-10-27

HICKMAN PLASTIC SUBCUTANEOUS PORT

Applicant C.R. Bard, Inc.

K number K873213

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LJT 1987-09-15

POLYURETHANE CATHETER FOR THE INFUSE-A-PORT

Applicant Shiley Infusaid, Inc.

K number K872898

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LJT 1987-08-25

NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)

Applicant Norfolk Medical Products, Inc.

K number K872838

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LJT 1987-08-04

SURECATH-ITP PERCUTANEOUS ACCESS KIT

Applicant Titan Medical, Inc.

K number K872149

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LJT 1987-08-04

UNIPORT MODEL SD-60, SD-70

Applicant Healthcare Technologies, Inc.

K number K870950

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LJT 1987-07-30

MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT

Applicant C.R. Bard, Inc.

K number K870817

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LJT 1987-06-24

NORFOLK MEDICAL NORPORT

Applicant Norfolk Medical Products, Inc.

K number K871209

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LJT 1987-06-10

SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT

Applicant Norfolk Medical Products, Inc.

K number K871192

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LJT 1987-05-07

NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT

Applicant Norfolk Medical Products, Inc.

K number K870187

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LJT 1987-05-06

LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER

Applicant Strato Medical Corp.

K number K870886

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LJT 1987-04-15

SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT

Applicant Norfolk Medical Products, Inc.

K number K870519

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LJT 1987-04-15

HICKMAN TITANIUM SUBCUTANEOUS PORT

Applicant C.R. Bard, Inc.

K number K870260

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LJT 1987-03-31

PORT-A-CATH VASCULAR ACCESS SYSTEMS

Applicant Pharmacia, Inc.

K number K864446

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LJT 1987-02-10

MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT

Applicant C.R. Bard, Inc.

K number K864349

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LJT 1986-12-01

HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER

Applicant C.R. Bard, Inc.

K number K863750

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LJT 1986-11-13

LIFE-PORT IMPLANTABLE VASCULAR ACCESS

Applicant Strato Medical Corp.

K number K853827

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LJT 1986-10-29

NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT

Applicant Norfolk Medical Products, Inc.

K number K863723

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LJT 1986-10-10

HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER

Applicant C.R. Bard, Inc.

K number K863305

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LJT 1986-09-11

INFUSE-A-PORT EXPLANT KIT

Applicant Intermedics/Infusaid, Inc.

K number K863296

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LJT 1986-09-03

MICRO PORT

Applicant Intermedics/Infusaid, Inc.

K number K862018

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LJT 1986-07-17

HDC CHEMO-PORT (VASCULAR)

Applicant Hdc Corp.

K number K853332

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LJT 1986-06-12

MEDTRONIC MODEL 8501 ACCESS PORT

Applicant Medtronic Vascular

K number K861498

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LJT 1986-01-09

IMPLANTOFIX

Applicant Burron Medical Products, Inc.

K number K851293

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LJT 1985-12-18

INFUSAID INFUSE-A-PORT (MODIFIED)

Applicant Intermedics/Infusaid, Inc.

K number K853981

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LJT 1985-11-26

PORT-GARD

Applicant Cormed, Inc., Sub. C.R.Bard, Inc.

K number K854019

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LJT 1985-11-06

MEDTRONIC ACCESS PORT MODEL 8500

Applicant Medtronic Vascular

K number K853322

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LJT 1985-05-17

STERILE CORMED MEDIPORT

Applicant Cormed, Inc., Sub. C.R.Bard, Inc.

K number K850967

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LJT 1985-05-07

PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV

Applicant Creative Care Systems, Inc.

K number K850888

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LJT 1984-09-18

INFUSE-A-PORT HEPARIN LOCK MAINT KIT

Applicant Infusaid Corp.

K number K840481

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LJT 1984-08-06

INFUSAID INFUSE-A-PORT

Applicant Infusaid Corp.

K number K842355

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LJT 1984-06-28

VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD

Applicant Norfolk Medical Products, Inc.

K number K841679

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LJT 1984-04-24

VASCULAR-ACCESS PORT CHANGE CATHETER

Applicant Norfolk Medical Products, Inc.

K number K841150

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LJT 1984-04-24

VASCULAR-ACCESS PORT - ENLARGEMENT

Applicant Norfolk Medical Products, Inc.

K number K841149

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LJT 1984-04-24

VASCULAR ACCESS PORT CHANGES IN MATER

Applicant Norfolk Medical Products, Inc.

K number K840788

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LJT 1983-12-28

PORT-A-CATH

Applicant Pharmacia, Inc.

K number K832917

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LJT 1983-09-15

INFUSE-A-PORT

Applicant Infusaid Corp.

K number K832788

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LJT 1983-06-30

PORT-A-CATH IMPLANTABLE CATH. SYS

Applicant Pharmacia, Inc.

K number K830730

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LJT 1983-03-01

VASCULAR-ACCESS-PORT

Applicant Norfolk Medical Products, Inc.

K number K830000

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LJT 1983-01-12

INFUSE-A-PORT

Applicant Infusaid Corp.

K number K823838

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