Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
FDA 510(k) clearance K230503 · decided 2023-04-25
Clearance details
- K-number
- K230503
- Device name
- Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-02-24
- Decision date
- 2023-04-25
- Days to decision
- 60 days
- Clearance type
- Traditional
- 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.