K973167 is an FDA 510(k) clearance for the POSITIVE PRESSURE CONNECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on November 17, 1997, 84 days after receiving the submission on August 25, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K973167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1997 |
| Decision Date | November 17, 1997 |
| Days to Decision | 84 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 |