Submission Details
| 510(k) Number | K111182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2011 |
| Decision Date | May 24, 2011 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ANGIOJET SOLENT OMNI THROMBECTOMY SET
May 2011
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K111182 is an FDA 510(k) clearance for the ANGIOJET SOLENT OMNI THROMBECTOMY SET, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 24, 2011, 27 days after receiving the submission on April 27, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEZ — Aspiration Thrombectomy Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |
Manufacturer
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