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 |