Product code LYK
- Device name
- Angioscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253842 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp | 2026-01-28 |
| K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp | 2025-10-01 |
| K062340 | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM | Cardio-Optics, Inc. | 2006-11-30 |
| K050808 | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 | Cardio-Optics, Inc. | 2005-07-28 |
| K011793 | KSEA FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | 2002-04-17 |
| K012724 | SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 | Smith & Nephew, Inc. | 2001-11-08 |
| K001408 | KSEA VASCULAR FIBERSCOPES | KARL STORZ Endoscopy-America, Inc. | 2000-10-30 |
| K964061 | GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) | W. L. Gore & Associates, Inc. | 1997-02-20 |
| K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ | Baxter Edwards | 1995-07-28 |
| K951721 | APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE | Applied Medical Resources | 1995-07-11 |
| K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | Applied Medical Resources | 1995-02-10 |
| K941715 | ULTATHIN FLEXIBLE ENDOSCOPE | Technology Marketing Group | 1994-10-04 |
| K934696 | ANGIOSCOPE | Intramed Laboratories, Inc. | 1994-01-18 |
| K931464 | BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE | Baxter Healthcare Corp | 1993-10-18 |
| K930758 | DIAGNOSTIC INTRAVASCULAR CATHETER | Applied Medical Resources | 1993-09-24 |
| K931421 | DISPOSABLE STEERABLE ANGIOSCOPE | Endovascular, Inc. | 1993-06-16 |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Baxter Edwards | 1993-03-23 |
| K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | Clarus Medical Systems, Inc. | 1993-02-25 |
| K923996 | DISPOSABLE VASCULAR ANGIOSCOPE | Endovascular, Inc. | 1993-01-13 |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | American Medical Technology, Inc. | 1992-04-23 |
| K914570 | DISPOSABLE VASCULAR ANGIOSCOPE | Nobles-Lai | 1992-01-27 |
| K913129 | ANGIOLAZ ANGIOSCOPE CATHETER | Angiolaz, Inc. | 1991-12-27 |
| K913763 | INTERPRET(TM) CATHETER LINEAR TRANSLATOR | Intertherapy, Inc. | 1991-11-20 |
| K911090 | OMEGA ANGIOSCOPES (OMEGASCOPES) | Omega Universal Technologies, Ltd. | 1991-07-31 |
| K911278 | OLYMPUS AF ANGIOSCOPE SYSTEM | Olympus Corp. | 1991-07-17 |
| K905083 | 4.5F IMAGECATH ANGIOSCOPE | Baxter Healthcare Corp | 1991-06-21 |
| K902329 | ULTRA-VU ANGIOSCOPE | Angiolaz, Inc. | 1990-08-22 |
| K895538 | ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY | Trimedyne, Inc. | 1990-04-26 |
| K900305 | INTRAVASCULAR IMAGING SYSTEMS | Intertherapy, Inc. | 1990-04-20 |
| K897153 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1990-03-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07540292000126 | Vena Camera Control Unit | Vena Medical Holdings Corp. | 2025-11-17 |
| 07540292001239 | Vena MicroAngioscope | Vena Medical Holdings Corp. | 2025-11-17 |