HI-TORQUE PROGRESS GUIDE WIRE FAMILY
FDA 510(k) clearance K091825 · decided 2009-09-25
Clearance details
- K-number
- K091825
- Device name
- HI-TORQUE PROGRESS GUIDE WIRE FAMILY
- Applicant
- Abbott Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-19
- Decision date
- 2009-09-25
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| XACT Carotid Stent System (P040038/S047) | Abbott Vascular, Inc. | 2025-03-09 |
| Perclose ProGlide Suture-Mediated Closure System, Prostar XL Percutaneous Vascular Surgical System (P960043/S125) | Abbott Vascular, Inc. | 2025-03-09 |