Vena MicroAngioscope System
FDA 510(k) K251767 · Vena Medical Holdings Corp
510(k) numberK251767
Submission
- Device name
- Vena MicroAngioscope System
- Applicant
- Vena Medical Holdings Corp
Kitchener, CA - Received
- June 10, 2025
- Decision date
- October 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K945591 | Applied Medical Optical ValvulotomeLYK · Traditional | Applied Medical Resources | 02/10/1995SE |
More from Applied Medical Resources
| 510(k) | Device | Decision |
|---|---|---|
| K253842 | Vena MicroAngioscope SystemLYK · Traditional | 01/28/2026SE |
Questions and answers
When was Vena MicroAngioscope System cleared by the FDA?
Vena MicroAngioscope System (K251767) received a 510(k) decision of Substantially Equivalent on October 1, 2025, 113 days after the submission was received.
What is the product code of K251767?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.