The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockert V172-28 Venous Femoral Cannula.
Device ID | K022321 |
510k Number | K022321 |
Device Name: | STOCKERT V172-28 VENOUS FEMORAL CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | STOCKERT INSTRUMENTE GMBH 14401 W. 65th Way Arvada, CO 80004 -3599 |
Contact | Shawn Riedel |
Correspondent | Shawn Riedel STOCKERT INSTRUMENTE GMBH 14401 W. 65th Way Arvada, CO 80004 -3599 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-17 |
Decision Date | 2002-10-09 |
Summary: | summary |