EZFLOW MAX, MODEL 1007— 510(k) K993558

Substantially Equivalent

Piper Medical Products

FDA 510(k) clearance K993558 for EZFLOW MAX, MODEL 1007, Substantially Equivalent on 1999-11-12. Applicant: Piper Medical Products.

Clearance details

Applicant: Piper Medical Products
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1999-10-20
Decision date: 1999-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.