SUPERCATH5
FDA 510(k) clearance K140419 · decided 2014-05-12
Clearance details
- K-number
- K140419
- Device name
- SUPERCATH5
- Applicant
- Togo Medikit Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-18
- Decision date
- 2014-05-12
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bunkyo-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.