OPEN END SPRING GUIDE— 510(k) K832607

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K832607 for OPEN END SPRING GUIDE, Substantially Equivalent on 1983-12-27. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1983-08-03
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrendale, PA, 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.