510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924385Substantially Equivalent

New Hydrophilic Coating for Wire Guides

Arrow Intl., Inc., Reading PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924385 is the FDA 510(k) clearance record for NEW HYDROPHILIC COATING FOR WIRE GUIDES, a class II device, cleared for Arrow Intl., Inc. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K924385.

Clearance record

Decision date
Received
(356 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow Intl., Inc. P.O. Box 12888, Reading PA
510(k) summary
Statement
Third party review
No

Clearances, product code DQX

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