K925362 is an FDA 510(k) clearance for the SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 28, 1993, 310 days after receiving the submission on October 22, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K925362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1992 |
| Decision Date | August 28, 1993 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |