INTRODUCING CATHETER
FDA 510(k) clearance K883933 · decided 1988-12-02
Clearance details
- K-number
- K883933
- Device name
- INTRODUCING CATHETER
- Applicant
- Devices For Vascular Intervention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-15
- Decision date
- 1988-12-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.