8F FlowGate2 Balloon Guide Catheter
FDA 510(k) clearance K153729 · decided 2016-01-27
Clearance details
- K-number
- K153729
- Device name
- 8F FlowGate2 Balloon Guide Catheter
- Applicant
- Concentric Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-12-28
- Decision date
- 2016-01-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 recall (Z-1907-2024) | Stryker Neurovascular | 2024-05-28 |
| FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) recall (Z-2569-2018) | Stryker Neurovascular | 2018-07-28 |