The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert A272 Series Pediatric Aortic Cannulae.
Device ID | K002273 |
510k Number | K002273 |
Device Name: | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | STOECKERT INSTRUMENTE 14401 W. 65th Way Arvada, CO 80004 -3599 |
Contact | Barbara Watson |
Correspondent | Barbara Watson STOECKERT INSTRUMENTE 14401 W. 65th Way Arvada, CO 80004 -3599 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-26 |
Decision Date | 2001-01-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
38033178004634 | K002273 | 000 |