SKIPPER AND SKIPPER RACE GUIDEWIRE— 510(k) K050756

Substantially Equivalent

Invatec Innovative Technologies, S.R.L.

FDA 510(k) clearance K050756 for SKIPPER AND SKIPPER RACE GUIDEWIRE, Substantially Equivalent on 2005-05-05. Applicant: Invatec Innovative Technologies, S.R.L..

Clearance details

Applicant: Invatec Innovative Technologies, S.R.L.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2005-03-23
Decision date: 2005-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.