SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY— 510(k) K124007

Substantially Equivalent

Micro Therapeutics, Inc. D/B/A: Ev3, Inc.

FDA 510(k) clearance K124007 for SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY, Substantially Equivalent on 2013-03-07. Applicant: Micro Therapeutics, Inc. D/B/A: Ev3, Inc..

Clearance details

Applicant: Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2012-12-26
Decision date: 2013-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.