K053188 is an FDA 510(k) clearance for the REPROCESSED BALOON INFLATION DEVICE. This device is classified as a Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed (Class II - Special Controls, product code NKU).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 4, 2006, 170 days after receiving the submission on November 15, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K053188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2005 |
| Decision Date | May 04, 2006 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NKU — Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |