Cleared Special

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

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K252527 · Merit Medical System, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
30d
Days
Class 2
Risk

K252527 is an FDA 510(k) clearance for the Surfacer Inside-Out Access Catheter System. Classified as Reverse Central Venous Recanalization System (product code QJH), Class II - Special Controls.

Submitted by Merit Medical System, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 10, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1342 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical System, Inc. devices

Submission Details

510(k) Number K252527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 11, 2025
Decision Date September 10, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJH Reverse Central Venous Recanalization System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1342
Definition A Reverse Central Venous Recanalization System Is A Prescription Device Intended For Obtaining Central Venous Access To Facilitate Catheter Insertion Into The Central Venous System. Reverse Recanalization Involves The Initiation Of An Access Path From Within The Vein And Then Progressing To The Skin For Patients With Upper Body Venous Occlusions Or Other Conditions That Preclude Central Venous Access By Other Methods.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05050799 Recruiting Observational Industry-sponsored

US Post-Market Surveillance Study of the Surfacer System

US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)

30
Patients (est.)
6
Sites
Condition studied Venous Disease
Eligibility All sexes · 18 Years+
Sponsor Merit Medical Systems, Inc. (industry)
Started 2022-02-08 → Primary completion 2026-12-15
Primary outcome
Central Venous Access operational
View full study on ClinicalTrials.gov