The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Clearlink Luer Activated Valve, Clearlink System Non-dehp Catheter Extension Sets.
| Device ID | K112893 |
| 510k Number | K112893 |
| Device Name: | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565762 | K112893 | 000 |
| 50085412049002 | K112893 | 000 |
| 50085412048968 | K112893 | 000 |
| 50085412048951 | K112893 | 000 |
| 50085412048944 | K112893 | 000 |
| 50085412048937 | K112893 | 000 |
| 50085412048920 | K112893 | 000 |
| 50085412048913 | K112893 | 000 |
| 50085412048906 | K112893 | 000 |
| 50085412048890 | K112893 | 000 |
| 50085412046384 | K112893 | 000 |
| 50085412049019 | K112893 | 000 |
| 50085412049026 | K112893 | 000 |
| 50085412049095 | K112893 | 000 |
| 50085412565632 | K112893 | 000 |
| 50085412082603 | K112893 | 000 |
| 50085412082597 | K112893 | 000 |
| 50085412080944 | K112893 | 000 |
| 50085412079757 | K112893 | 000 |
| 20085412071651 | K112893 | 000 |
| 50085412071195 | K112893 | 000 |
| 50085412070051 | K112893 | 000 |
| 50085412051722 | K112893 | 000 |
| 50085412051319 | K112893 | 000 |
| 50085412656644 | K112893 | 000 |