Device, Intravascular Catheter Securement

FDA product code KMK · 64 cleared devices

Class 1 General Hospital

Regulation: 21 CFR 880.5210
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-03-14 – 2019-07-09

KMK 2019-07-09

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

Applicant Interrad Medical, Inc.

K number K180994

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KMK 1999-06-03

A P HARNESS

Applicant Paraworks Enterprise, Ltd.

K number K981860

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KMK 1996-10-11

MULTI-PURPOSE MEDICAL TUBE HOLDER

Applicant Byrd Medical Devices, Inc.

K number K963365

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KMK 1995-08-09

SECURE-SITE

Applicant Op-Co Medical Products , Ltd.

K number K941098

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KMK 1994-09-29

STATLOCK CV

Applicant Venetec, Inc.

K number K943147

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KMK 1994-09-14

IV START KITS

Applicant Sterile Concepts, Inc.

K number K943047

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KMK 1994-07-14

IMMOBILE STERILE AND IMMOBILE A/C STERILE

Applicant Tnt Moborg Intl. , Ltd.

K number K941940

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KMK 1994-07-14

IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE

Applicant Tnt Moborg Intl. , Ltd.

K number K941850

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KMK 1994-03-07

CONMED VENI-GARD I.V. DRESSING

Applicant Conmedcorp

K number K935389

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KMK 1994-02-18

K-LOK CATHETER SECUREMENT DEVICE MODIFICATION

Applicant K-Lok, Inc.

K number K935252

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KMK 1994-02-09

CENTERMARK SECURING WINGS

Applicant Menlo Care, Inc.

K number K940127

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KMK 1993-12-08

SECURODRIP (TM) I.V. ARMBOARD

Applicant Op-Co Medical Products , Ltd.

K number K932757

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KMK 1993-10-15

DUODERM TRANSPARENT HYDROCOLLOID DRESSING

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K925992

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KMK 1993-09-30

IV COMFORT PAD

Applicant D.J. Scott Mfg., Inc.

K number K930663

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KMK 1993-08-03

IAB ANCHOR

Applicant Datascope Corp.

K number K922103

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KMK 1993-04-21

K-LOK CATHETER SECUREMENT DEVICE

Applicant K-Lok, Inc.

K number K930225

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KMK 1993-04-20

KWIK BOARD

Applicant Astral, Ltd.

K number K930197

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KMK 1993-03-16

I.V. PRO

Applicant I.V. - Pro Tek, Inc.

K number K924180

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KMK 1993-02-05

ILS(TM) - INVASIVE LINE SEPARATOR

Applicant 2-Rn Corp.

K number K924369

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KMK 1993-02-03

DERMASSIST TRANSPARENT SITE DRESSING

Applicant Wilshire Medical Products

K number K924249

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KMK 1993-01-12

TRACE MODEL# 840, 841,842 & 845 ARM BOARD

Applicant Trace Medical Equipment, Inc.

K number K925502

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KMK 1992-11-23

TUBE, LEAD, AND CORD HOLDER NO. 102

Applicant Ansley Medical Products, Inc.

K number K924568

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KMK 1992-11-23

FOLEY CATHETER TUBE HOLDER NO. 101

Applicant Ansley Medical Products, Inc.

K number K924567

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KMK 1992-11-23

RESTRAINT, PROTECTIVE N0. 103

Applicant Ansley Medical Products, Inc.

K number K924566

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KMK 1992-04-06

DESERET POSITIONAL SUTURE WING

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K915495

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KMK 1991-12-04

SECURODRIP

Applicant Op-Co Medical Products , Ltd.

K number K912660

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KMK 1991-09-25

IV HOUSE

Applicant Progressive Iv'S, Inc.

K number K912942

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KMK 1991-08-09

INTRAVASCULAR CATHETER SECURMENT DEVICE

Applicant Inman Liebelt Corp.

K number K912211

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KMK 1991-07-05

PICC-FIX

Applicant Sorex Medical

K number K911070

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KMK 1991-06-06

COMFOR-BOARD

Applicant Medway

K number K910880

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KMK 1991-01-18

GENNY DENNY IV SHIELD

Applicant Tadco, Inc.

K number K905735

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KMK 1990-07-09

BABY BOARDS IV SUPPORT ASSEMBLY

Applicant Baby Boards, Inc.

K number K900134

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KMK 1990-01-31

TRANSPARENT FILM I.V. SITE/WOUND DRESSING

Applicant Catalina Biomedical Corp.

K number K896421

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KMK 1990-01-11

VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE

Applicant Vitaphore Corp.

K number K896046

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KMK 1990-01-11

VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE

Applicant Vitaphore Corp.

K number K895993

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KMK 1989-10-13

JOHNSON & JOHNSON TUBE SECUREMENT DEVICE

Applicant Johnson & Johnson Patient Care, Inc.

K number K895431

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KMK 1989-08-15

DALE I.V. IDENTIFIER; PRODUCT #1125

Applicant Dale Medical Products, Inc.

K number K894586

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KMK 1987-11-05

DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220

Applicant Dale Medical Products, Inc.

K number K873311

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KMK 1987-04-23

TIMLEINE(TM) VENIPUNCTURE SYSTEM

Applicant Ipax, Inc.

K number K870770

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KMK 1987-01-14

E-Z HOLD - #4060

Applicant John F. Greer Co., Inc.

K number K864190

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KMK 1986-03-21

IV BAND (INTRAVENOUS CATHETER ASSESORY)

Applicant T. G. & E. Medical

K number K860706

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KMK 1986-01-27

HOLD-IT FRAMED ADHESIVE FILM

Applicant Vlv Associates, Inc.

K number K860071

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KMK 1986-01-09

I.V. DRESSING

Applicant Consolidated Medical Equipment, Inc.

K number K854040

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KMK 1985-09-20

SAFTI-BRACELET

Applicant Advanced Biosearch Assn.

K number K853418

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KMK 1985-04-01

SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS

Applicant Turn Needle Intl., Inc.

K number K850503

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KMK 1984-11-05

TRENDS LANCET

Applicant Orange Medical Instruments, Inc.

K number K843882

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KMK 1984-09-24

VENI-SHIELD

Applicant U.S. Mfg. & Management, Inc.

K number K842999

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KMK 1984-08-15

ACU-DERM TRANSPARENT IV DRESSING

Applicant Acme United Corp.

K number K842064

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KMK 1984-06-28

INTRAVASCULAR CATHETER SECUREMENT DEV

Applicant Tapemark Co.

K number K841487

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KMK 1984-03-06

FPP IV SECURE

Applicant Fpp, Inc.

K number K840683

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KMK 1983-10-04

I.V. FILTER HOLDER

Applicant Saxnor Corp.

K number K832300

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KMK 1983-03-01

FREHAN INC. I.V. FILTER HOLDER

Applicant Saxnor Corp.

K number K830300

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KMK 1982-09-24

LINEGUARD CATHETER SHIELD MODEL 100

Applicant Ray-Marshall Laboratory

K number K822732

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KMK 1982-07-28

CATH-LOK

Applicant Hpd Medical, Inc.

K number K821957

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KMK 1982-06-24

EZ-FIX I.V. CATHETER HOLDER

Applicant Dyna Care

K number K821796

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KMK 1982-05-28

UNIVERSAL I.V. HOLDER

Applicant Georgetown Medical Co.

K number K821317

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KMK 1982-05-14

VEIN-SHIELD

Applicant Pan-Tech Research, Inc.

K number K820759

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KMK 1981-08-03

AEGIS I.V. STRIPS

Applicant Warner-Lambert Co.

K number K812080

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KMK 1981-03-26

ADHESIVE I.V. CATHETER DRESSING

Applicant Johnson & Johnson Professionals, Inc.

K number K810579

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KMK 1980-05-08

EYEWI ANKORS

Applicant Eyevi & Co.

K number K800726

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KMK 1980-01-29

I.V. TAPE DOWN HOLDER

Applicant Consolidated Medical Equipment, Inc.

K number K800024

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KMK 1979-11-20

I.V. STRIP

Applicant E-Med Corp.

K number K792049

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KMK 1978-12-07

GRIP, HOSPITAL UTILITY

Applicant Baka Manufacturing Co., Inc.

K number K781800

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KMK 1977-03-14

I.V. LOK TM

Applicant Jelco Laboratories

K number K770119

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