The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Flowease [subcutaneous] Infusion Set.
| Device ID | K121092 |
| 510k Number | K121092 |
| Device Name: | FLOWEASE [SUBCUTANEOUS] INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
| Contact | Niedre M Heckman |
| Correspondent | Niedre M Heckman BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50642621029258 | K121092 | 000 |
| 50642621029241 | K121092 | 000 |
| 50642621029234 | K121092 | 000 |