CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER— 510(k) K132197

Substantially Equivalent

Pendracare International, B.V.

FDA 510(k) clearance K132197 for CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER, Substantially Equivalent on 2013-08-12. Applicant: Pendracare International, B.V..

Clearance details

Applicant: Pendracare International, B.V.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2013-07-16
Decision date: 2013-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.