PROGIGY SUPPORT CATHETER— 510(k) K130714

Substantially Equivalent

Radius Medical, LLC

FDA 510(k) clearance K130714 for PROGIGY SUPPORT CATHETER, Substantially Equivalent on 2013-08-22. Applicant: Radius Medical, LLC.

Clearance details

Applicant: Radius Medical, LLC
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2013-03-15
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hudson, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.