HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
FDA 510(k) clearance K101116 · decided 2010-06-23
Clearance details
- K-number
- K101116
- Device name
- HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
- Applicant
- Abbott Vascular-Cardiac Therapies
- Decision
- Substantially Equivalent
- Date received
- 2010-04-21
- Decision date
- 2010-06-23
- Days to decision
- 63 days
- Clearance type
- Special
- 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.
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