The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockert Coronary Perfusion Cannulae.
| Device ID | K022280 |
| 510k Number | K022280 |
| Device Name: | STOCKERT CORONARY PERFUSION CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | STOCKERT INSTRUMENTE GMBH 20193 GOINS DR. Morrison, CO 80465 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard STOCKERT INSTRUMENTE GMBH 20193 GOINS DR. Morrison, CO 80465 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-10-11 |
| Summary: | summary |