Surfacer Inside-Out Access Catheter System— 510(k) K252527

Name: FDA 510(k) clearance K252527
Creator: U.S. Food and Drug Administration
Published: 2025-09-10

Unknown

Merit Medical System, Inc.

FDA 510(k) clearance K252527 for Surfacer Inside-Out Access Catheter System, Unknown on 2025-09-10. Applicant: Merit Medical System, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical System, Inc.
Product code: Code QJH
Device class: Class 2
Regulation: 21 CFR 870.1342
Advisory panel: Cardiovascular
Date received: 2025-08-11
Decision date: 2025-09-10
Decision: Unknown
Clearance type: Special
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.