CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
FDA 510(k) clearance K003880 · decided 2001-05-16
Clearance details
- K-number
- K003880
- Device name
- CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-15
- Decision date
- 2001-05-16
- Days to decision
- 152 days
- Clearance type
- Abbreviated
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Moutian View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.