Atlas FDA

LYK

41 FDA 510(k) clearances · Product code

133 daysmedian time to decision
254 days90th percentile
41clearances measured

FDA profile

Official device name
Angioscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
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RecordFirmDate
Vena MicroAngioscope™ System (K253842)Vena Medical Holdings Corp2026-01-28
Vena MicroAngioscope™ System (K251767)Vena Medical Holdings Corp2025-10-01
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (K062340)Cardio-Optics, Inc.2006-11-30
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808)Cardio-Optics, Inc.2005-07-28
KSEA FIBERSCOPE (K011793)KARL STORZ Endoscopy-America, Inc.2002-04-17
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (K012724)Smith & Nephew, Inc.2001-11-08
KSEA VASCULAR FIBERSCOPES (K001408)KARL STORZ Endoscopy-America, Inc.2000-10-30
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061)W. L. Gore & Associates, Inc.1997-02-20
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638)Baxter Edwards1995-07-28
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
APPLIED MEDICAL OPTICAL VALVULOTOME (K945591)Applied Medical Resources1995-02-10
ULTATHIN FLEXIBLE ENDOSCOPE (K941715)Technology Marketing Group1994-10-04
ANGIOSCOPE (K934696)Intramed Laboratories, Inc.1994-01-18
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE (K931464)Baxter Healthcare Corp1993-10-18
DIAGNOSTIC INTRAVASCULAR CATHETER (K930758)Applied Medical Resources1993-09-24
DISPOSABLE STEERABLE ANGIOSCOPE (K931421)Endovascular, Inc.1993-06-16
4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (K926433)Baxter Edwards1993-03-23
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE (K924554)Clarus Medical Systems, Inc.1993-02-25
DISPOSABLE VASCULAR ANGIOSCOPE (K923996)Endovascular, Inc.1993-01-13
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM (K905745)American Medical Technology, Inc.1992-04-23
DISPOSABLE VASCULAR ANGIOSCOPE (K914570)Nobles-Lai1992-01-27
ANGIOLAZ ANGIOSCOPE CATHETER (K913129)Angiolaz, Inc.1991-12-27
INTERPRET(TM) CATHETER LINEAR TRANSLATOR (K913763)Intertherapy, Inc.1991-11-20
OMEGA ANGIOSCOPES (OMEGASCOPES) (K911090)Omega Universal Technologies, Ltd.1991-07-31
OLYMPUS AF ANGIOSCOPE SYSTEM (K911278)Olympus Corp.1991-07-17
4.5F IMAGECATH ANGIOSCOPE (K905083)Baxter Healthcare Corp1991-06-21
ULTRA-VU ANGIOSCOPE (K902329)Angiolaz, Inc.1990-08-22
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY (K895538)Trimedyne, Inc.1990-04-26
INTRAVASCULAR IMAGING SYSTEMS (K900305)Intertherapy, Inc.1990-04-20
CVIS INSIGHT IMAGING CATHETER (K897153)Cardiovascular Imaging Systems, Inc.1990-03-26
INTRAVASCULAR IMAGING SYSTEM (K895159)Intertherapy, Inc.1990-03-12
ANGIOSCOPE (K894459)Intramed Laboratories, Inc.1990-03-07
HEMOLASER HEMOSCOPE (K893816)Hemolaser Corp.1990-02-01
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM (K890047)Vascucare, Inc.1989-06-20
ACS ANGIOSCOPE GUIDE WIRE (K883000)Advanced Cardiovascular Systems, Inc.1988-09-28
ACS CORONARY ANGIOSCOPIC CATHETER (K875108)Advanced Cardiovascular Systems, Inc.1988-09-27
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE (K860858)Olympus Corp.1986-11-20
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE (K842481)American Edwards Laboratories1984-10-18
ANGIOSCOPY CATHETER (K834547)American Edwards Laboratories1984-06-11
ANGIOSCOPY CATHETER (K832698)American Edwards Laboratories1983-11-03
ANGIOSCOPE (K830084)Trimedyne, Inc.1983-06-02

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