K082806 is an FDA 510(k) clearance for the SPINNING SPIROS, MODEL CH-2000. 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 April 6, 2009, 194 days after receiving the submission on September 24, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K082806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2008 |
| Decision Date | April 06, 2009 |
| Days to Decision | 194 days |
| Submission Type | Special |
| 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 |