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 |