510(k) Report

FDA applicant

Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)

Reading, PA1 decision2015–20151 recall

FDA records 1 decision for Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) (Reading, PA) in 2015: 1 510(k) clearance. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2015high 1 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K151513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 20152cite it

What has FDA decided for it lately?

  • K151513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 20151 recall

The one decision as Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151513ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 &…Dec 15, 2017Class II

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 Int'L. 1Arrow Industries, LLC 1Arrow International, Teleflex 1Arrow Products, Inc. 1Arrow International, Inc (Subsidiary of Teleflex I 1Arrow International, Inc. (Subsidiary of Telelflex Inc.) 1