FLEX SCORING CATHETER
FDA 510(k) clearance K152789 · decided 2016-05-25
Clearance details
- K-number
- K152789
- Device name
- FLEX SCORING CATHETER
- Applicant
- Venturemed Group
- Decision
- Substantially Equivalent
- Date received
- 2015-09-25
- Decision date
- 2016-05-25
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- PNO
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylvania, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.