SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
FDA 510(k) clearance K124007 · decided 2013-03-07
Clearance details
- K-number
- K124007
- Device name
- SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
- Applicant
- Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-03-07
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.