The following data is part of a premarket notification filed by Cardio-optics, Inc. with the FDA for Coronary Sinus Access Kit, Model Kcs8f-01.
| Device ID | K050808 |
| 510k Number | K050808 |
| Device Name: | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 |
| Classification | Angioscope |
| Applicant | CARDIO-OPTICS, INC. 2477 55TH ST., SUITE 120 Boulder, CO 80301 |
| Contact | Larry Blankenship |
| Correspondent | Larry Blankenship CARDIO-OPTICS, INC. 2477 55TH ST., SUITE 120 Boulder, CO 80301 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-07-28 |
| Summary: | summary |