LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
FDA 510(k) clearance K951744 · decided 1995-05-04
Clearance details
- K-number
- K951744
- Device name
- LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1995-03-30
- Decision date
- 1995-05-04
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.