Crosstella OTW
FDA 510(k) clearance K160004 · decided 2016-04-29
Clearance details
- K-number
- K160004
- Device name
- Crosstella OTW
- Applicant
- KANEKA Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-01-04
- Decision date
- 2016-04-29
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.