The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Administration Sets With 0.2 Micron Filter.
| Device ID | K153158 |
| 510k Number | K153158 |
| Device Name: | Solution Administration Sets With 0.2 Micron Filter |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N WILSON ROAD Round Lake, IL 60073 |
| Contact | Gary Chumbimune |
| Correspondent | Gary Chumbimune BAXTER HEALTHCARE CORPORATION 32650 N WILSON ROAD 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 | 2015-11-02 |
| Decision Date | 2015-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565755 | K153158 | 000 |
| 50085412002281 | K153158 | 000 |
| 50085412003998 | K153158 | 000 |
| 50085412013713 | K153158 | 000 |
| 50085412046322 | K153158 | 000 |
| 50085412046339 | K153158 | 000 |
| 50085412048494 | K153158 | 000 |
| 50085412048517 | K153158 | 000 |
| 50085412065323 | K153158 | 000 |
| 50085412071669 | K153158 | 000 |
| 50085412079672 | K153158 | 000 |
| 50085412080951 | K153158 | 000 |
| 50085412002274 | K153158 | 000 |