Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
FDA 510(k) clearance K143604 · decided 2015-06-25
Clearance details
- K-number
- K143604
- Device name
- Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
- Applicant
- Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
- Decision
- Substantially Equivalent
- Date received
- 2014-12-18
- Decision date
- 2015-06-25
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Catalca, TR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.