The following data is part of a premarket notification filed by Voss Medical Products with the FDA for Voss Disposable Coronary Bypass Flushing Cannula.
Device ID | K896338 |
510k Number | K896338 |
Device Name: | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | VOSS MEDICAL PRODUCTS 4227 CENTERGATE San Antonio, TX 78217 |
Contact | Steve Holloway |
Correspondent | Steve Holloway VOSS MEDICAL PRODUCTS 4227 CENTERGATE San Antonio, TX 78217 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-03 |
Decision Date | 1990-05-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811304020096 | K896338 | 000 |
00811304020065 | K896338 | 000 |