Panels › Gastroenterology, Urology › Product code LYK · Class 2
Angioscope
Regulation 876.1500
1510(k)s in 12 months (41 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LYK
| Company | 510(k)s | Recalls |
|---|---|---|
| American Edwards Laboratories | 3 | 0 |
| Applied Medical Resources | 3 | 0 |
| Intertherapy, Inc. | 3 | 0 |
| Advanced Cardiovascular Systems, Inc. | 2 | 0 |
| Angiolaz, Inc. | 2 | 0 |
| Baxter Edwards | 2 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| Cardio-Optics, Inc. | 2 | 0 |
| Endovascular, Inc. | 2 | 0 |
| Intramed Laboratories, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2026 | K253842 | Vena MicroAngioscope System Vena Medical Holdings Corp, CA | LYK |
| Oct 1, 2025 | K251767 | Vena MicroAngioscope System Vena Medical Holdings Corp, CA | LYK |
| Nov 30, 2006 | K062340 | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM Cardio-Optics, Inc. | LYK |
| Jul 28, 2005 | K050808 | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 Cardio-Optics, Inc. | LYK |
| Apr 17, 2002 | K011793 | KSEA FIBERSCOPE KARL STORZ Endoscopy-America, Inc. | LYK |
| Nov 8, 2001 | K012724 | SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 Smith & Nephew, Inc. | LYK |
| Oct 30, 2000 | K001408 | KSEA VASCULAR FIBERSCOPES KARL STORZ Endoscopy-America, Inc. | LYK |
| Feb 20, 1997 | K964061 | GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) W. L. Gore & Associates, Inc. | LYK |
| Jul 28, 1995 | K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ Baxter Edwards | LYK |
| Jul 11, 1995 | K951721 | APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE Applied Medical Resources | LYK |
| Feb 10, 1995 | K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME Applied Medical Resources | LYK |
| Oct 4, 1994 | K941715 | ULTATHIN FLEXIBLE ENDOSCOPE Technology Marketing Group | LYK |
| Jan 18, 1994 | K934696 | ANGIOSCOPE Intramed Laboratories, Inc. | LYK |
| Oct 18, 1993 | K931464 | BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE Baxter Healthcare Corp | LYK |
| Sep 24, 1993 | K930758 | DIAGNOSTIC INTRAVASCULAR CATHETER Applied Medical Resources | LYK |
| Jun 16, 1993 | K931421 | DISPOSABLE STEERABLE ANGIOSCOPE Endovascular, Inc. | LYK |
| Mar 23, 1993 | K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 Baxter Edwards | LYK |
| Feb 25, 1993 | K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE Clarus Medical Systems, Inc. | LYK |
| Jan 13, 1993 | K923996 | DISPOSABLE VASCULAR ANGIOSCOPE Endovascular, Inc. | LYK |
| Apr 23, 1992 | K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM American Medical Technology, Inc. | LYK |
| Jan 27, 1992 | K914570 | DISPOSABLE VASCULAR ANGIOSCOPE Nobles-Lai | LYK |
| Dec 27, 1991 | K913129 | ANGIOLAZ ANGIOSCOPE CATHETER Angiolaz, Inc. | LYK |
| Nov 20, 1991 | K913763 | INTERPRET(TM) CATHETER LINEAR TRANSLATOR Intertherapy, Inc. | LYK |
| Jul 31, 1991 | K911090 | OMEGA ANGIOSCOPES (OMEGASCOPES) Omega Universal Technologies, Ltd. | LYK |
| Jul 17, 1991 | K911278 | OLYMPUS AF ANGIOSCOPE SYSTEM Olympus Corp. | LYK |
| Jun 21, 1991 | K905083 | 4.5F IMAGECATH ANGIOSCOPE Baxter Healthcare Corp | LYK |
| Aug 22, 1990 | K902329 | ULTRA-VU ANGIOSCOPE Angiolaz, Inc. | LYK |
| Apr 26, 1990 | K895538 | ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY Trimedyne, Inc. | LYK |
| Apr 20, 1990 | K900305 | INTRAVASCULAR IMAGING SYSTEMS Intertherapy, Inc. | LYK |
| Mar 26, 1990 | K897153 | CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. | LYK |
| Mar 12, 1990 | K895159 | INTRAVASCULAR IMAGING SYSTEM Intertherapy, Inc. | LYK |
| Mar 7, 1990 | K894459 | ANGIOSCOPE Intramed Laboratories, Inc. | LYK |
| Feb 1, 1990 | K893816 | HEMOLASER HEMOSCOPE Hemolaser Corp. | LYK |
| Jun 20, 1989 | K890047 | VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM Vascucare, Inc. | LYK |
| Sep 28, 1988 | K883000 | ACS ANGIOSCOPE GUIDE WIRE Advanced Cardiovascular Systems, Inc. | LYK |
| Sep 27, 1988 | K875108 | ACS CORONARY ANGIOSCOPIC CATHETER Advanced Cardiovascular Systems, Inc. | LYK |
| Nov 20, 1986 | K860858 | OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE Olympus Corp. | LYK |
| Oct 18, 1984 | K842481 | AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE American Edwards Laboratories | LYK |
| Jun 11, 1984 | K834547 | ANGIOSCOPY CATHETER American Edwards Laboratories | LYK |
| Nov 3, 1983 | K832698 | ANGIOSCOPY CATHETER American Edwards Laboratories | LYK |
| Jun 2, 1983 | K830084 | ANGIOSCOPE Trimedyne, Inc. | LYK |
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