K100576 is an FDA 510(k) clearance for the HIGH PRESSURE SETS-400 PSI. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 17, 2010, 291 days after receiving the submission on March 1, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K100576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2010 |
| Decision Date | December 17, 2010 |
| Days to Decision | 291 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 |