ITC CONTOUR EMBOLI, MODIFICATION
FDA 510(k) clearance K914866 · decided 1993-11-09
Clearance details
- K-number
- K914866
- Device name
- ITC CONTOUR EMBOLI, MODIFICATION
- Applicant
- Interventional Therapeutics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-29
- Decision date
- 1993-11-09
- Days to decision
- 742 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.