CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)— 510(k) K070212

Substantially Equivalent

Ovalum , Ltd.

FDA 510(k) clearance K070212 for CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM), Substantially Equivalent on 2007-10-12. Applicant: Ovalum , Ltd..

Clearance details

Applicant: Ovalum , Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2007-01-22
Decision date: 2007-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

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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.