K070532 is an FDA 510(k) clearance for the SPIROS. 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 March 20, 2007, 22 days after receiving the submission on February 26, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K070532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2007 |
| Decision Date | March 20, 2007 |
| Days to Decision | 22 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 |