GALTSTICK INTRODUCER SYSTEM— 510(k) K071330

Substantially Equivalent

Galt Medical Corp.

FDA 510(k) clearance K071330 for GALTSTICK INTRODUCER SYSTEM, Substantially Equivalent on 2007-10-31. Applicant: Galt Medical Corp..

Clearance details

Applicant: Galt Medical Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2007-05-11
Decision date: 2007-10-31
Decision: Substantially Equivalent
Clearance type: Special
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.