PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid— 510(k) K253791

Name: FDA 510(k) clearance K253791
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

DePuy Mitek, Inc.

FDA 510(k) clearance K253791 for PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid, Substantially Equivalent on 2026-02-26. Applicant: DePuy Mitek, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Mitek, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2025-11-28
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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