Coaxial Dilator Set (Micro-Introducer)— 510(k) K172487

Unknown

Galt Medical Corp.

FDA 510(k) clearance K172487 for Coaxial Dilator Set (Micro-Introducer), Unknown on 2017-10-16. Applicant: Galt Medical Corp..

Clearance details

Applicant: Galt Medical Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2017-08-17
Decision date: 2017-10-16
Decision: Unknown
Clearance type: Traditional
Location: Garland, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.