CORFLO 300 PUMP— 510(k) K944750

Substantially Equivalent - Subject to Tracking & PMS

Corpak, Inc.

FDA 510(k) clearance K944750 for CORFLO 300 PUMP, Substantially Equivalent - Subject to Tracking & PMS on 1995-06-19. Applicant: Corpak, Inc..

Clearance details

Applicant: Corpak, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1994-09-26
Decision date: 1995-06-19
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.