The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Set With 1.2 Micron Air Eliminating Filter.
| Device ID | K161808 |
| 510k Number | K161808 |
| Device Name: | Solution Set With 1.2 Micron Air Eliminating Filter |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | John Lamela |
| Correspondent | John Lamela 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 | 2016-07-01 |
| Decision Date | 2017-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565670 | K161808 | 000 |