K052428 is an FDA 510(k) clearance for the RESOLUTION ENDOVASCULAR SYSTEM. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).
Submitted by Omnisonics Medical Technologies (Wilmington, US). The FDA issued a Cleared decision on December 8, 2005, 97 days after receiving the submission on September 2, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature..
| 510(k) Number | K052428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2005 |
| Decision Date | December 08, 2005 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEY — Mechanical Thrombolysis Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature. |