Z FLEX-270TM STEERABLE SHEATH— 510(k) K112541

Substantially Equivalent

Great Batch Medical

FDA 510(k) clearance K112541 for Z FLEX-270TM STEERABLE SHEATH, Substantially Equivalent on 2012-02-07. Applicant: Great Batch Medical.

Clearance details

Applicant: Great Batch Medical
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2011-09-01
Decision date: 2012-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.