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

Name: FDA 510(k) clearance K132197
Creator: U.S. Food and Drug Administration
Published: 2013-08-12

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.. Device class: 2.

Clearance details

Applicant: Pendracare International, B.V.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2013-07-16
Decision date: 2013-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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K120585 — CONVEY GUIDING CATHETER2012-08-08

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.