GUIDANT BALLOON CATHETER, SEVERAL MODELS
FDA 510(k) clearance K021283 · decided 2002-05-02
Clearance details
- K-number
- K021283
- Device name
- GUIDANT BALLOON CATHETER, SEVERAL MODELS
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-18
- Decision date
- 2002-05-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.