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 |