Cleared Traditional

Primum Hydrophilic Guiding Catheter

K250972 · Pendracare · Cardiovascular
Jun 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250972 is an FDA 510(k) clearance for the Primum Hydrophilic Guiding Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Pendracare (Leek, NL). The FDA issued a Cleared decision on June 29, 2025, 90 days after receiving the submission on March 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250972 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date June 29, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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