MICRO-GUIDE SYSTEM
FDA 510(k) clearance K884337 · decided 1989-01-05
Clearance details
- K-number
- K884337
- Device name
- MICRO-GUIDE SYSTEM
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
- Decision
- Substantially Equivalent
- Date received
- 1988-10-14
- Decision date
- 1989-01-05
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chicago, IL, 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.