K992532 is an FDA 510(k) clearance for the VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on June 13, 2000, 320 days after receiving the submission on July 29, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K992532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1999 |
| Decision Date | June 13, 2000 |
| Days to Decision | 320 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |