GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
FDA 510(k) clearance K072990 · decided 2007-10-31
Clearance details
- K-number
- K072990
- Device name
- GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-24
- Decision date
- 2007-10-31
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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| WIRION (K143570) | Gardia Medical | 2015-06-04 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
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