510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162988Substantially Equivalent

PreludeSYNC Radial Compression Device

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

K162988 is the FDA 510(k) clearance record for PreludeSYNC Radial Compression Device, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show one recall naming K162988.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
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 DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260