The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 3 Lead Extension With 2 Interlink Injection Sites.
| Device ID | K915390 |
| 510k Number | K915390 |
| Device Name: | 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Marcia Marconi |
| Correspondent | Marcia Marconi BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20085412004765 | K915390 | 000 |