ANGIOJET SOLENT OMNI THROMBECTOMY SET
FDA 510(k) clearance K111182 · decided 2011-05-24
Clearance details
- K-number
- K111182
- Device name
- ANGIOJET SOLENT OMNI THROMBECTOMY SET
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-27
- Decision date
- 2011-05-24
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Ste recall (Z-2378-2015) | Boston Scientific Corporation | 2015-08-13 |