The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Set/extension Set.
| Device ID | K142011 |
| 510k Number | K142011 |
| Device Name: | SOLUTION SET/EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | Tiffany Lin |
| Correspondent | Tiffany Lin 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 | 2014-07-24 |
| Decision Date | 2014-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412079764 | K142011 | 000 |
| 50085412003813 | K142011 | 000 |
| 50085412003837 | K142011 | 000 |
| 50085412003844 | K142011 | 000 |
| 50085412003905 | K142011 | 000 |
| 50085412003912 | K142011 | 000 |
| 50085412014864 | K142011 | 000 |
| 50085412021091 | K142011 | 000 |
| 50085412031564 | K142011 | 000 |
| 50085412032080 | K142011 | 000 |
| 50085412079689 | K142011 | 000 |
| 50085412079696 | K142011 | 000 |
| 50085412079702 | K142011 | 000 |
| 50085412079719 | K142011 | 000 |
| 50085412079726 | K142011 | 000 |
| 50085412001819 | K142011 | 000 |