510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884490Substantially Equivalent

Introducer Safety Syringe

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

K884490 is the FDA 510(k) clearance record for INTRODUCER SAFETY SYRINGE, 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 K884490.

Clearance record

Decision date
Received
(83 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 6306, Reading PA
Third party review
No

Clearances, product code DQX

Trailing 12 months
13 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 20261