SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300— 510(k) K010497

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K010497 for SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300, Substantially Equivalent on 2001-03-22. Applicant: Micro Therapeutics, Inc..

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2001-02-21
Decision date: 2001-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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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.