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
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K981782Substantially Equivalent

Low Profile Port Attachable Catheter with Blue Flex Tip / 8Fr. Inroducer Kit Implantable Vascular Access System

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

K981782 is the FDA 510(k) clearance record for LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM, a class II device, cleared for Arrow Intl., Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K981782.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow Intl., Inc. 1600 Providence Hwy., Walpole MA
510(k) summary
Statement
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260