K152528 is an FDA 510(k) clearance for the Attachable Cath Lab Hemostasis Valve. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 2, 2015, 90 days after receiving the submission on September 3, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K152528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2015 |
| Decision Date | December 02, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTL - Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4290 |