LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE— 510(k) K921674

Substantially Equivalent

Strato Medical Corp.

FDA 510(k) clearance K921674 for LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE, Substantially Equivalent on 1992-09-23. Applicant: Strato Medical Corp..

Clearance details

Applicant: Strato Medical Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1992-04-08
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.