510(k) K945588— DISPOSABLE 1CC SYRINGE WITH LUER LOCK

Substantially Equivalent

Interventional Therapeutics Corp.

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1994-11-14
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.