Ultra-Vu Angioscope
FDA 510(k) K902329 · Angiolaz, Inc.
510(k) numberK902329
Submission
- Device name
- Ultra-Vu Angioscope
- Applicant
- Angiolaz, Inc.
Rockingham, VT, US - Received
- May 24, 1990
- Decision date
- August 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LYK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253842 | Vena MicroAngioscope SystemLYK · Traditional | Vena Medical Holdings Corp | 01/28/2026SE |
| K251767 | Vena MicroAngioscope SystemLYK · Traditional | Vena Medical Holdings Corp | 10/01/2025SE |
| K062340 | Cardiooptics Augmentative Cardiac Optical Imaging SystemLYK · Traditional | Cardio-Optics, Inc. | 11/30/2006SE |
| K050808 | Coronary Sinus Access Kit, Model KCS8F-01LYK · Traditional | Cardio-Optics, Inc. | 07/28/2005SE |
| K011793 | Ksea FiberscopeLYK · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/17/2002SE |
| K012724 | Smith & Nephew Vascular Videoendoscope System, Model 7209273LYK · Traditional | Smith & Nephew, Inc. | 11/08/2001SE |
| K001408 | Ksea Vascular FiberscopesLYK · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/30/2000SE |
| K964061 | Gore Angioscopic Valvvlotome Kit (TBD)LYK · Traditional | W. L. Gore & Associates, Inc. | 02/20/1997SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | Baxter Edwards | 07/28/1995SE |
| K951721 | Applied Medical 1.5MM Reusable AngioscopeLYK · Traditional | Applied Medical Resources | 07/11/1995SE |
More from Applied Medical Resources
| 510(k) | Device | Decision |
|---|---|---|
| K994362 | Headlamp HL2000.FSR · Traditional | 05/11/2000SE |
| K992447 | 50 W Metal Halide Illuminator, Ves 0501.FCW · Traditional | 10/20/1999SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | 08/21/1998SE |
| K981819 | Angiolaz VES-1CAMFWF · Traditional | 08/04/1998SE |
| K981821 | Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional | 07/29/1998SE |
| K981827 | Ves 0281-M Complete Video Endoscopic Video SystemFET · Traditional | 07/28/1998SE |
| K933868 | Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesGCT · Traditional | 11/10/1993SE |
| K913129 | Angiolaz Angioscope CatheterLYK · Traditional | 12/27/1991SE |
Questions and answers
When was Ultra-Vu Angioscope cleared by the FDA?
Ultra-Vu Angioscope (K902329) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 90 days after the submission was received.
What is the product code of K902329?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.