The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Vantex Central Venous Catheter With Oligon Material With Or Without Amc Thromboshield Coating.
| Device ID | K992532 |
| 510k Number | K992532 |
| Device Name: | VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Jason Smith |
| Correspondent | Jason Smith BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-29 |
| Decision Date | 2000-06-13 |
| Summary: | summary |