510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K915238Substantially Equivalent

Trac-Wright Trac 10 Catheter

Dow Corning Wright, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915238 is the FDA 510(k) clearance record for TRAC-WRIGHT TRAC 10 CATHETER, a class II device, cleared for Dow Corning Wright on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 74 510(k) clearances for Dow Corning Wright, from to . As of , FDA records show no recalls naming K915238.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Dow Corning Wright 14320 NW 60th Ave., Miami Lakes FL
510(k) summary
Statement
Third party review
No

Clearances, product code MCW

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