STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA 510(k) clearance K082344 · decided 2008-12-17
Clearance details
- K-number
- K082344
- Device name
- STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
- Applicant
- Sorin Group Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-08-15
- Decision date
- 2008-12-17
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5. recall (Z-2075-2010) | Sorin Group USA, Inc. | 2010-07-22 |