The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Centrasil Silicone Elastomer Central Venous Cath.
| Device ID | K881215 |
| 510k Number | K881215 |
| Device Name: | CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Dennis Ocwieja |
| Correspondent | Dennis Ocwieja BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-06-13 |