ANGIOJET SOLENT DISTA THROMBECTOMY SET
FDA 510(k) clearance K113363 · decided 2012-06-06
Clearance details
- K-number
- K113363
- Device name
- ANGIOJET SOLENT DISTA THROMBECTOMY SET
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-15
- Decision date
- 2012-06-06
- Days to decision
- 204 days
- Clearance type
- Traditional
- 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 Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Usi recall (Z-2379-2015) | Boston Scientific Corporation | 2015-08-13 |