K953573 is an FDA 510(k) clearance for the ICU STOPCOK WITH EXTENSION TUBING. 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 October 7, 1995, 68 days after receiving the submission on July 31, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K953573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1995 |
| Decision Date | October 07, 1995 |
| Days to Decision | 68 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 |