The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Non-dehp Micro-volume Extension Set With 0.22 Micron Filter.
| Device ID | K113227 |
| 510k Number | K113227 |
| Device Name: | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER |
| Classification | Filter, Infusion Line |
| Applicant | BAXTER HEALTHCARE CORP. 1 BAXTER PKWY. Deerfield, IL 60015 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1 BAXTER PKWY. Deerfield, IL 60015 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412082023 | K113227 | 000 |
| 50085412004841 | K113227 | 000 |
| 50085412004810 | K113227 | 000 |
| 50085412004773 | K113227 | 000 |
| 50085412004711 | K113227 | 000 |