510(k) Report

FDA applicant

Arrow Int'L.

Reading, PA1 decision2004–200415 recalls

FDA records 1 decision for Arrow Int'L. (Reading, PA) in 2004: 1 510(k) clearance. All are in product code MSD (Catheter, Hemodialysis, Implanted). Its devices cite 1 predicate, 0 of them its own earlier devices. 15 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Arrow Int'L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arrow Int'L. since 2007.

Recalls per year

15in 2008

2008: 15
2007high 15 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arrow Int'L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MSDCatheter, Hemodialysis, Implanted1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040260Integral Hemodialysis CatheterArrow Int'L. · 20042cite it

What has FDA decided for it lately?

  • K040260Integral Hemodialysis CatheterArrow Int'L. · 200415 recalls

The one decision as Arrow Int'L. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K040260ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm…Jun 10, 2008
  • K040260ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff…Jun 10, 2008
  • K040260ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to…Jun 10, 2008
  • K040260ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff…Jun 10, 2008
  • K040260ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm…Jun 10, 2008
  • K040260ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff…Jun 10, 2008

Other applicant names beginning “Arrow”

FDA records each applicant name separately; these may or may not be the same firm.

Arrow Intl., Inc. 110Arrow International, Inc. 22Arrow International, Inc. (Subsidiary of Teleflex, Inc.) 17Arrow International, LLC (A subsidiary of Teleflex… 6Arrow X-Ray Corp. 2Arrow Industries, LLC 1Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) 1Arrow International, Teleflex 1Arrow Products, Inc. 1Arrow International, Inc (Subsidiary of Teleflex I 1Arrow International, Inc. (Subsidiary of Telelflex Inc.) 1