K070979 is an FDA 510(k) clearance for the PULL TAB SQUEEZE FLUSH. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2007, 166 days after receiving the submission on April 6, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K070979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2007 |
| Decision Date | September 19, 2007 |
| Days to Decision | 166 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |