K925126 is an FDA 510(k) clearance for the INTERLINK(TM) INJECTION SITE. 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 June 18, 1993, 248 days after receiving the submission on October 13, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K925126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1992 |
| Decision Date | June 18, 1993 |
| Days to Decision | 248 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 |