BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
FDA 510(k) clearance K232651 · decided 2023-09-29
Clearance details
- K-number
- K232651
- Device name
- BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-08-31
- Decision date
- 2023-09-29
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- 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.
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