System, Balloon, Intra-Aortic And Control

FDA product code DSP · 161 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3535
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-06 – 2025-03-26

DSP 1990-08-17

PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON

Applicant Datascope Corp.

K number K896497

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DSP 1990-04-19

SERIES 3001 IABP

Applicant Boston Scientific Corp

K number K900281

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DSP 1990-04-10

ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS

Applicant Aries Medical, Inc.

K number K895433

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DSP 1990-03-06

SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER

Applicant Boston Scientific Corp

K number K896920

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DSP 1990-02-12

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.

Applicant Boston Scientific Corp

K number K896597

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DSP 1990-02-05

PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI

Applicant Datascope Corp.

K number K896430

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DSP 1989-09-26

SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER

Applicant Boston Scientific Corp

K number K894942

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DSP 1989-09-20

8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

Applicant Kontron Instruments, Inc.

K number K892799

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DSP 1989-09-20

9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

Applicant Kontron Instruments, Inc.

K number K892798

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DSP 1989-09-20

10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

Applicant Kontron Instruments, Inc.

K number K892797

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DSP 1989-09-13

KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000

Applicant Kontron Instruments, Inc.

K number K892878

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DSP 1989-06-20

INTRA AORTIC BALLOON

Applicant Datascope Corp.

K number K893243

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DSP 1989-03-20

9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON

Applicant Kontron Instruments, Inc.

K number K882508

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DSP 1989-03-20

10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC

Applicant Kontron Instruments, Inc.

K number K882274

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DSP 1988-06-10

DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL

Applicant Datascope Corp.

K number K880289

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DSP 1988-05-18

INTRA-AORTIC BALLOON PUMP MODEL KAAT

Applicant Kontron Instruments, Inc.

K number K875036

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DSP 1988-04-01

KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000

Applicant Kontron Instruments, Inc.

K number K874816

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DSP 1987-06-19

40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER

Applicant Aries Medical, Inc.

K number K864994

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DSP 1987-06-19

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

Applicant Aries Medical, Inc.

K number K864537

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DSP 1987-05-12

40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER

Applicant Aries Medical, Inc.

K number K864568

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DSP 1987-05-12

40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER

Applicant Aries Medical, Inc.

K number K864567

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DSP 1987-01-16

40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON

Applicant Aries Medical, Inc.

K number K863185

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DSP 1987-01-14

SYSTEM 90 TRANSPORT

Applicant Datascope Corp.

K number K863219

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DSP 1986-10-01

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON

Applicant Kontron Instruments, Inc.

K number K860638

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DSP 1986-05-09

MONARK 869 ERGOMETER

Applicant Equilibrated Bio Systems, Inc.

K number K855102

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DSP 1986-05-07

KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT

Applicant Kontron Instruments, Inc.

K number K860427

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DSP 1986-01-22

INTRA-AORTIC BALLOON PUMP MODEL K2000

Applicant Kontron Instruments, Inc.

K number K853062

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DSP 1985-12-11

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT

Applicant Smec, Inc.

K number K840367

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DSP 1985-08-22

DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

Applicant Datascope Corp.

K number K850482

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DSP 1985-02-20

ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO

Applicant Aries Medical, Inc.

K number K844220

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DSP 1985-02-08

PERCOR 9.5 FR IAB ON DATASCOPE CO2

Applicant Datascope Corp.

K number K833828

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DSP 1985-02-08

IABP #90 SYSTEM

Applicant Datascope Corp.

K number K831235

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DSP 1985-02-01

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC

Applicant Smec, Inc.

K number K840037

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DSP 1984-10-13

PERCUTANEOUS BALLOON

Applicant Smec, Inc.

K number K832753

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DSP 1984-05-16

ARIES MEDICAL MODEL 700

Applicant Aries Medical, Inc.

K number K833632

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DSP 1983-11-02

FRENCH INTRA-AORTIC 9.5 BALLOON ON KON

Applicant Datascope Corp.

K number K831397

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DSP 1983-11-02

PECOR 8.5 FRENCH IAB ON A DATASCOPE

Applicant Datascope Corp.

K number K831307

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DSP 1983-04-27

MINISCOPE MS-2

Applicant Jedmed Instrument Co.

K number K830411

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DSP 1983-04-27

EK COMBI MSG-1

Applicant Jedmed Instrument Co.

K number K830410

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DSP 1983-02-18

INTRA-AORTIC BALLOON SYSTEM

Applicant Smec, Inc.

K number K823739

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DSP 1983-01-24

PERCOR INTRA-AORTIC BALLOON INSERTION

Applicant Datascope Corp.

K number K823342

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DSP 1982-12-21

DATASCOPE MODEL 83 IABP SYSTEM

Applicant Datascope Corp.

K number K821951

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DSP 1982-12-15

SMEC BALLOON SYSTEM

Applicant Smec, Inc.

K number K823177

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DSP 1982-10-18

PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC

Applicant Datascope Corp.

K number K820882

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DSP 1982-08-19

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL

Applicant Datascope Corp.

K number K821065

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DSP 1982-07-02

MODIFICATION OF THE PERCUTAN-BALLOON

Applicant Smec, Inc.

K number K813355

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DSP 1982-04-29

ADAPTATION OF KANTRON 40 CC. PDLIAB

Applicant Kontron Instruments, Inc.

K number K820166

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DSP 1982-03-31

DATASCOPE MODIFIED #82 IABP SYSTEM

Applicant Datascope Corp.

K number K813182

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DSP 1981-12-02

FUKUDA DENSHI CARDIMAX FK-11

Applicant Brentwood Instruments, Inc.

K number K813023

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DSP 1981-08-03

MODEL 84 TRANSPORT SYSTEM

Applicant Datascope Corp.

K number K811372

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DSP 1981-05-06

DATASCOPE PERCOR=DL DUAL-LUMEN INTRA

Applicant Datascope Corp.

K number K810297

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DSP 1981-03-11

KONTRON PERCUTAEOUS DOUBLE-LUMEN

Applicant Avco Medical Products

K number K802924

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DSP 1981-01-13

PERCOR DATASCOPE INTRA-AORTIC BALLOON

Applicant Datascope Corp.

K number K802167

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DSP 1981-01-13

DATASCOPE/AVCO CONNECTOR

Applicant Datascope Corp.

K number K801601

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DSP 1980-05-14

SMEC BALLOON CANNULA

Applicant Smec, Inc.

K number K790755

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DSP 1979-10-01

INTRA-AORTIC BALLOON, TYPE S

Applicant Datascope Corp.

K number K790775

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DSP 1979-02-23

INTRA-AORTIC BALLOON-PUMP

Applicant Avco Medical Products

K number K790241

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DSP 1979-01-23

PUMP, BALLOON MODEL 10

Applicant Avco Medical Products

K number K781848

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DSP 1978-03-15

BALLOON PUMP

Applicant Datascope Corp.

K number K780280

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DSP 1977-05-06

PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT

Applicant Avco Medical Products

K number K770821

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DSP 1976-10-06

TAMARI-KAPLITT

Applicant Yehuda Tamari

K number K760695

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