510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153397Substantially Equivalent

S-Wire Guidewire System

Concert Medical, LLC, Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153397 is the FDA 510(k) clearance record for S-Wire Guidewire System, a class II device, cleared for Concert Medical, LLC on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 3 510(k) clearances for Concert Medical, LLC, from to . As of , FDA records show no recalls naming K153397.

Clearance record

Decision date
Received
(268 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Concert Medical, LLC 77 Accord Park Dr., Norwell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260