primeMidline Catheters— 510(k) K192802

Substantially Equivalent

Pfm Medical, Inc.

FDA 510(k) clearance K192802 for primeMidline Catheters, Substantially Equivalent on 2019-10-28. Applicant: Pfm Medical, Inc..

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code PND
Advisory panel: General Hospital
Date received: 2019-09-30
Decision date: 2019-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.