The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Paclitaxel Sets.
| Device ID | K160007 |
| 510k Number | K160007 |
| Device Name: | Paclitaxel Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | Tiffany Lin |
| Correspondent | Tiffany Lin BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD 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 | 2016-01-04 |
| Decision Date | 2016-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565779 | K160007 | 000 |
| 50085412071683 | K160007 | 000 |
| 50085412046377 | K160007 | 000 |
| 50085412036385 | K160007 | 000 |
| 50085412036378 | K160007 | 000 |