Cvis Insight Imaging Catheter
FDA 510(k) K897153 · Cardiovascular Imaging Systems, Inc.
510(k) numberK897153
Submission
- Device name
- Cvis Insight Imaging Catheter
- Applicant
- Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US - Received
- December 26, 1989
- Decision date
- March 26, 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 |
|---|---|---|
| K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional | 06/20/1997SE |
| K942231 | Microview Ii/Microrail II CathetersDQO · Traditional | 08/01/1994SE |
| K933517 | Automatic Pull Back DeviceDQX · Traditional | 10/15/1993SE |
| K930232 | Cvis Insight Imaging Guide CatheterDQO · Traditional | 07/21/1993SE |
| K924922 | Cvis Insight Imaging CatheterDQO · Traditional | 06/29/1993SE |
| K930311 | Cvis LongviewDQO · Traditional | 06/02/1993SE |
| K921879 | Cbis Catheter Pull-Back DeviceDQO · Traditional | 07/16/1992SE |
| K921750 | Cvis Insight III SystemITX · Traditional | 07/13/1992SE |
| K921631 | Cvis Insight Imaging Catheter for IntraluminalITX · Traditional | 07/02/1992SE |
| K921148 | Cvis Insight Catheters for Intracardiac UseITX · Traditional | 06/16/1992SE |
Questions and answers
When was Cvis Insight Imaging Catheter cleared by the FDA?
Cvis Insight Imaging Catheter (K897153) received a 510(k) decision of Substantially Equivalent on March 26, 1990, 90 days after the submission was received.
What is the product code of K897153?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.