510(k) K964061
- Device
- GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K964061
- Product code
- LYK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-20
- Date received
- 1996-10-10
- Regulation
- 876.1500
- Classification name
- Angioscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAWN LOPEZ
- Address
- 1505 N. Fourth St. P.O. Box 3000 Flagstaff AZ US 86003 86003
FDA Registration Numbers#
- 2020550
- 1221826
- 3009905888
- 1319639
- 9610617
- 3014342096
- 1225984
- 3010202439
- 3016481619
Source Documents#
Other 510(k) Records For Product Code LYK #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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