091 Balloon Guide Catheter
FDA 510(k) clearance K220331 · decided 2022-07-29
Clearance details
- K-number
- K220331
- Device name
- 091 Balloon Guide Catheter
- Applicant
- Inneuroco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-04
- Decision date
- 2022-07-29
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pembroke Pines, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.