510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K022117Substantially Equivalent

Majestik (Tm) Shielded Angiography Needle, Model Stan18t71w-25, Majestik (Tm) Shielded Angiogtaphy Needle, Sran18t71wr-5

Merit Medical Systems, Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022117 is the FDA 510(k) clearance record for MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code DRC (Trocar). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K022117.

Clearance record

Decision date
Received
(102 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRC

Trailing 12 months

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

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