THEROX INFUSION GUIDEWIRES
FDA 510(k) clearance K971719 · decided 1997-11-03
Clearance details
- K-number
- K971719
- Device name
- THEROX INFUSION GUIDEWIRES
- Applicant
- Therox, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-09
- Decision date
- 1997-11-03
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.