K941190 is an FDA 510(k) clearance for the CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on January 31, 1995, 323 days after receiving the submission on March 14, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K941190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1994 |
| Decision Date | January 31, 1995 |
| Days to Decision | 323 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 |