INTHERM RADIALLY EXPANDING DILATER— 510(k) K912971

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K912971 for INTHERM RADIALLY EXPANDING DILATER, Substantially Equivalent on 1991-09-13. Applicant: Interventional Therapeutics Corp..

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1991-07-08
Decision date: 1991-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.