primeMidline Catheters— 510(k) K173114

Name: FDA 510(k) clearance K173114
Creator: U.S. Food and Drug Administration
Published: 2018-03-07

Substantially Equivalent

Pfm Medical, Inc.

FDA 510(k) clearance K173114 for primeMidline Catheters, Substantially Equivalent on 2018-03-07. Applicant: Pfm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2017-09-29
Decision date: 2018-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K210047 — Stiletto Extended Dwell Catheter2021-08-27
K192802 — primeMidline Catheters2019-10-28

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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.