510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252527Unknown

Surfacer Inside-Out Access Catheter System

Merit Medical System, Inc., South Jordan UT / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252527 is the FDA 510(k) clearance record for Surfacer Inside-Out Access Catheter System, a class II device, cleared for Merit Medical System, Inc. on under FDA product code QJH (Reverse Central Venous Recanalization System). FDA's definition for product code QJH reads: "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...". FDA records list 5 510(k) clearances for Merit Medical System, Inc., from to . As of , FDA records show no recalls naming K252527.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QJH Reverse Central Venous Recanalization System
Regulation
21 CFR 870.1342
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical System, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJH

Trailing 12 months

FDA records hold no clearances under product code QJH in the trailing twelve months.

FDA records show no clearances under product code QJH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QJH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260