510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913682Substantially Equivalent

Merit Custom Kit

Merit Medical Systems, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913682 is the FDA 510(k) clearance record for MERIT CUSTOM KIT, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show 19 recalls naming K913682.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. 79 W. 4500 S., Suite 9, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260