The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35.
Device ID | K023622 |
510k Number | K023622 |
Device Name: | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 |
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 | 2002-10-29 |
Decision Date | 2002-11-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
38033178004627 | K023622 | 000 |
38033178004610 | K023622 | 000 |
38033178004603 | K023622 | 000 |
38033178004597 | K023622 | 000 |
38033178004580 | K023622 | 000 |