MOBICATH TRANSSEPTAL NEEDLE— 510(k) K122832

Substantially Equivalent

Great Batch Medical

FDA 510(k) clearance K122832 for MOBICATH TRANSSEPTAL NEEDLE, Substantially Equivalent on 2012-12-19. Applicant: Great Batch Medical.

Clearance details

Applicant: Great Batch Medical
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2012-09-17
Decision date: 2012-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.