ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
FDA 510(k) clearance K220654 · decided 2022-04-06
Clearance details
- K-number
- K220654
- Device name
- ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
- Applicant
- Cordis Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-03-07
- Decision date
- 2022-04-06
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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