510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924338Substantially Equivalent

Arrow-Fischell Extended Vascular Access Needle

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

K924338 is the FDA 510(k) clearance record for ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE, a class II device, cleared for Arrow Intl., Inc. on under FDA product code DRC (Trocar). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K924338.

Clearance record

Decision date
Received
(203 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
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 DRC

Trailing 12 months

FDA records hold no clearances under product code DRC in the trailing twelve months.

FDA records show no clearances under product code DRC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260