ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
FDA 510(k) clearance K972142 · decided 1997-08-25
Clearance details
- K-number
- K972142
- Device name
- ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-06
- Decision date
- 1997-08-25
- Days to decision
- 80 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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Recalls involving this device
No recalls on record reference this clearance.