K021692 is an FDA 510(k) clearance for the CLC2000 CATHETER PATENCY DEVICE. 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 December 4, 2003, 561 days after receiving the submission on May 22, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K021692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2002 |
| Decision Date | December 04, 2003 |
| Days to Decision | 561 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 |