The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets, Continued, Clearlink System Buretrol S.
| Device ID | K123874 |
| 510k Number | K123874 |
| Device Name: | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412078217 | K123874 | 000 |
| 50085412002786 | K123874 | 000 |
| 50085412050695 | K123874 | 000 |
| 50085412068201 | K123874 | 000 |
| 50085412071126 | K123874 | 000 |
| 50085412071188 | K123874 | 000 |
| 50085412071744 | K123874 | 000 |
| 50085412073359 | K123874 | 000 |
| 50085412073366 | K123874 | 000 |
| 50085412073410 | K123874 | 000 |
| 50085412075292 | K123874 | 000 |
| 50085412565700 | K123874 | 000 |