Attachable Cath Lab Hemostasis Valve— 510(k) K152528

Substantially Equivalent

Galt Medical Corp.

FDA 510(k) clearance K152528 for Attachable Cath Lab Hemostasis Valve, Substantially Equivalent on 2015-12-02. Applicant: Galt Medical Corp..

Clearance details

Applicant: Galt Medical Corp.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2015-09-03
Decision date: 2015-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.