Coronary Sinus Access Kit, Model KCS8F-01
FDA 510(k) K050808 · Cardio-Optics, Inc.
510(k) numberK050808
Submission
- Device name
- Coronary Sinus Access Kit, Model KCS8F-01
- Applicant
- Cardio-Optics, Inc.
Boulder, CO, US - Received
- March 30, 2005
- Decision date
- July 28, 2005
- 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
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| K964061 | Gore Angioscopic Valvvlotome Kit (TBD)LYK · Traditional | W. L. Gore & Associates, Inc. | 02/20/1997SE |
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| 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 |
|---|---|---|
| K062340 | Cardiooptics Augmentative Cardiac Optical Imaging SystemLYK · Traditional | 11/30/2006SE |
Questions and answers
When was Coronary Sinus Access Kit, Model KCS8F-01 cleared by the FDA?
Coronary Sinus Access Kit, Model KCS8F-01 (K050808) received a 510(k) decision of Substantially Equivalent on July 28, 2005, 120 days after the submission was received.
What is the product code of K050808?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.