510(k) Report

FDA applicant

Arrow International, Inc.

Reading, PA22 decisions2003–2025114 recalls

FDA records 22 decisions for Arrow International, Inc. (Reading, PA) from 2003 to 2025: 22 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and LJS (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 10 of them its own earlier devices. 114 recalls are linked to its devices, 23 Class I.

FDA’s records also spell it “Arrow International, LLC”.

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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 22012: 32013: 22014: 12017: 12019: 22020: 22023: 22025: 1
2007high 3 (2012) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

6in 2026

2008: 192010: 22011: 12012: 12013: 12014: 22015: 52016: 52017: 272018: 212019: 32020: 2, 2 Class I2022: 14, 13 Class I2023: 3, 2 Class I2024: 2, 2 Class I2026 (partial year): 6, 4 Class I
2007high 27 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DSPSystem, Balloon, Intra-Aortic And Control7decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days5decisions
  • MSDCatheter, Hemodialysis, Implanted4decisions
  • CAZAnesthesia Conduction Kit4decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • DQXWire, Guide, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 157 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 37 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 10 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.

  • K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 20075cite it
  • K080604Pressure Injfectable PiccArrow International, Inc. · 20084cite it
  • K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK…Arrow International, Inc. · 20034cite it
  • K061289Arrow Pressure Injectable PiccArrow International, Inc. · 20063cite it
  • K040078Cannon II PlusArrow International, Inc. · 20042cite it
  • K073451Pressure Injectable PiccArrow International, Inc. · 20082cite it

What has FDA decided for it lately?

  • K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC · 2025
  • K232343AC3™ Series IABPArrow International, LLC · 2023
  • K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC · 2023
  • K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 202011 Class I recalls
  • K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 20201 Class I recall
  • K190101UltraFlex IABArrow International, Inc. · 20191 Class I recall
  • K190117Fiberoptix IABArrow International, Inc. · 2019
  • K162820AC3 Series IABP SystemArrow International, Inc. · 20172 Class I recalls

All 19 as Arrow International, Inc. →All 3 as Arrow International, LLC →

What has been recalled?

114 recalls linked to its devices; the latest:

  • K001587Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY…Apr 21, 2026Class I
  • K042126Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45…Apr 21, 2026Class I
  • K071538Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR…Apr 21, 2026Class I
  • K141051Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI…Apr 10, 2026Class I
  • K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER…Mar 11, 2026Class II
  • K071538Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031AJan 7, 2026Class 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. (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 1Arrow International, Inc. (Subsidiary of Telelflex Inc.) 1