Super Sheath
FDA 510(k) clearance K200379 · decided 2020-03-19
Clearance details
- K-number
- K200379
- Device name
- Super Sheath
- Applicant
- Togo Medikit Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-18
- Decision date
- 2020-03-19
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hyuga City, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.