K964435 is an FDA 510(k) clearance for the PRIMARY IV SET. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 2, 1997, 148 days after receiving the submission on November 5, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K964435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1996 |
| Decision Date | April 02, 1997 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |