CLEARLUMEN THROMBECTOMY SYSTEM
FDA 510(k) clearance K140296 · decided 2014-12-02
Clearance details
- K-number
- K140296
- Device name
- CLEARLUMEN THROMBECTOMY SYSTEM
- Applicant
- Walk Vascular, LLC
- Decision
- Unknown
- Date received
- 2014-02-06
- Decision date
- 2014-12-02
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.