ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET— 510(k) K131950

Substantially Equivalent

Summit International Medical Technologies, Inc.

FDA 510(k) clearance K131950 for ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET, Substantially Equivalent on 2015-01-16. Applicant: Summit International Medical Technologies, Inc..

Clearance details

Applicant: Summit International Medical Technologies, Inc.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-27
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.