TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT— 510(k) K112398

Substantially Equivalent

Galt Medical

FDA 510(k) clearance K112398 for TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT, Substantially Equivalent on 2012-04-12. Applicant: Galt Medical.

Clearance details

Applicant: Galt Medical
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2011-08-19
Decision date: 2012-04-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Buford, GA, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.