PERIPHERAL CUTTING BALLOON
FDA 510(k) clearance K040155 · decided 2004-07-01
Clearance details
- K-number
- K040155
- Device name
- PERIPHERAL CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-01-23
- Decision date
- 2004-07-01
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- PNO
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.