Scoreflex PTA Scoring Balloon Catheter
FDA 510(k) clearance K182713 · decided 2019-06-11
Clearance details
- K-number
- K182713
- Device name
- Scoreflex PTA Scoring Balloon Catheter
- Applicant
- Orbusneich Medical Trading, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-27
- Decision date
- 2019-06-11
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- PNO
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.