510(k) Report

FDA applicant

Arrow International, Inc. (Subsidiary of Telelflex Inc.)

Reading, PA1 decision2017–20171 recall

FDA records 1 decision for Arrow International, Inc. (Subsidiary of Telelflex Inc.) (Reading, PA) in 2017: 1 510(k) clearance. All are in product code DQY (Catheter, Percutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1, 1 Class I
2017high 1 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Arrow International, Inc. (Subsidiary of Telelflex Inc.) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arrow International, Inc. (Subsidiary…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQYCatheter, Percutaneous1decision

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.

  • K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 20172cite it

What has FDA decided for it lately?

  • K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 20171 Class I recall

The one decision as Arrow International, Inc. (Subsidiary of Telelflex Inc.) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021120Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…Apr 21, 2026Class I

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 Internation, Inc. (Subsidiary of Teleflex Inc.) 1Arrow International, Teleflex 1Arrow Products, Inc. 1Arrow International, Inc (Subsidiary of Teleflex I 1