Primum Hydrophilic Guiding Catheter— 510(k) K250972

Name: FDA 510(k) clearance K250972
Creator: U.S. Food and Drug Administration
Published: 2025-06-29

Substantially Equivalent

Pendracare

FDA 510(k) clearance K250972 for Primum Hydrophilic Guiding Catheter, Substantially Equivalent on 2025-06-29. Applicant: Pendracare. Device class: 2.

Clearance details

Applicant: Pendracare
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2025-03-31
Decision date: 2025-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leek, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.