The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Vamp Venous/arterial Blood Management Protection.
| Device ID | K896819 |
| 510k Number | K896819 |
| Device Name: | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION |
| Classification | Catheter, Continuous Flush |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | M Taflinger |
| Correspondent | M Taflinger BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103199661 | K896819 | 000 |
| 07460691944794 | K896819 | 000 |
| 07460691944800 | K896819 | 000 |
| 07460691944817 | K896819 | 000 |
| 07460691949874 | K896819 | 000 |
| 07460691951525 | K896819 | 000 |
| 07460691951822 | K896819 | 000 |
| 07460691955578 | K896819 | 000 |
| 07460691957329 | K896819 | 000 |
| 07460691944787 | K896819 | 000 |