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 |