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Angioscope

FDA product code LYK · 41 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1500
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-06-02 – 2026-01-28

LYK 2026-01-28

Vena MicroAngioscope™ System

Applicant Vena Medical Holdings Corp

K number K253842

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LYK 2025-10-01

Vena MicroAngioscope™ System

Applicant Vena Medical Holdings Corp

K number K251767

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LYK 2006-11-30

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

Applicant Cardio-Optics, Inc.

K number K062340

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LYK 2005-07-28

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

Applicant Cardio-Optics, Inc.

K number K050808

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LYK 2002-04-17

KSEA FIBERSCOPE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K011793

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LYK 2001-11-08

SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273

Applicant Smith & Nephew, Inc.

K number K012724

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LYK 2000-10-30

KSEA VASCULAR FIBERSCOPES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K001408

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LYK 1997-02-20

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

Applicant W. L. Gore & Associates, Inc.

K number K964061

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LYK 1995-07-28

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

Applicant Baxter Edwards

K number K952638

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LYK 1995-07-11

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE

Applicant Applied Medical Resources

K number K951721

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LYK 1995-02-10

APPLIED MEDICAL OPTICAL VALVULOTOME

Applicant Applied Medical Resources

K number K945591

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LYK 1994-10-04

ULTATHIN FLEXIBLE ENDOSCOPE

Applicant Technology Marketing Group

K number K941715

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LYK 1994-01-18

ANGIOSCOPE

Applicant Intramed Laboratories, Inc.

K number K934696

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LYK 1993-10-18

BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE

Applicant Baxter Healthcare Corp

K number K931464

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LYK 1993-09-24

DIAGNOSTIC INTRAVASCULAR CATHETER

Applicant Applied Medical Resources

K number K930758

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LYK 1993-06-16

DISPOSABLE STEERABLE ANGIOSCOPE

Applicant Endovascular, Inc.

K number K931421

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LYK 1993-03-23

4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45

Applicant Baxter Edwards

K number K926433

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LYK 1993-02-25

CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE

Applicant Clarus Medical Systems, Inc.

K number K924554

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LYK 1993-01-13

DISPOSABLE VASCULAR ANGIOSCOPE

Applicant Endovascular, Inc.

K number K923996

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LYK 1992-04-23

AMETEC MASY MODULAR ANGIOSCOPE SYSTEM

Applicant American Medical Technology, Inc.

K number K905745

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LYK 1992-01-27

DISPOSABLE VASCULAR ANGIOSCOPE

Applicant Nobles-Lai

K number K914570

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LYK 1991-12-27

ANGIOLAZ ANGIOSCOPE CATHETER

Applicant Angiolaz, Inc.

K number K913129

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LYK 1991-11-20

INTERPRET(TM) CATHETER LINEAR TRANSLATOR

Applicant Intertherapy, Inc.

K number K913763

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LYK 1991-07-31

OMEGA ANGIOSCOPES (OMEGASCOPES)

Applicant Omega Universal Technologies, Ltd.

K number K911090

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LYK 1991-07-17

OLYMPUS AF ANGIOSCOPE SYSTEM

Applicant Olympus Corp.

K number K911278

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LYK 1991-06-21

4.5F IMAGECATH ANGIOSCOPE

Applicant Baxter Healthcare Corp

K number K905083

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LYK 1990-08-22

ULTRA-VU ANGIOSCOPE

Applicant Angiolaz, Inc.

K number K902329

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LYK 1990-04-26

ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY

Applicant Trimedyne, Inc.

K number K895538

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LYK 1990-04-20

INTRAVASCULAR IMAGING SYSTEMS

Applicant Intertherapy, Inc.

K number K900305

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LYK 1990-03-26

CVIS INSIGHT IMAGING CATHETER

Applicant Cardiovascular Imaging Systems, Inc.

K number K897153

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LYK 1990-03-12

INTRAVASCULAR IMAGING SYSTEM

Applicant Intertherapy, Inc.

K number K895159

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LYK 1990-03-07

ANGIOSCOPE

Applicant Intramed Laboratories, Inc.

K number K894459

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LYK 1990-02-01

HEMOLASER HEMOSCOPE

Applicant Hemolaser Corp.

K number K893816

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LYK 1989-06-20

VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM

Applicant Vascucare, Inc.

K number K890047

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LYK 1988-09-28

ACS ANGIOSCOPE GUIDE WIRE

Applicant Advanced Cardiovascular Systems, Inc.

K number K883000

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LYK 1988-09-27

ACS CORONARY ANGIOSCOPIC CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K number K875108

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LYK 1986-11-20

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE

Applicant Olympus Corp.

K number K860858

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LYK 1984-10-18

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE

Applicant American Edwards Laboratories

K number K842481

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LYK 1984-06-11

ANGIOSCOPY CATHETER

Applicant American Edwards Laboratories

K number K834547

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LYK 1983-11-03

ANGIOSCOPY CATHETER

Applicant American Edwards Laboratories

K number K832698

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LYK 1983-06-02

ANGIOSCOPE

Applicant Trimedyne, Inc.

K number K830084

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