INOUE BALLOON A
FDA 510(k) clearance K220881 · decided 2022-12-18
Clearance details
- K-number
- K220881
- Device name
- INOUE BALLOON A
- Applicant
- Toray Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-25
- Decision date
- 2022-12-18
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chuo-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.