510(k) Report

FDA applicant

Arrow Intl., Inc.

Reading, PA110 decisions1976–2010359 recalls

FDA records 110 decisions for Arrow Intl., Inc. (Reading, PA) from 1976 to 2010: 110 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and DQY (Catheter, Percutaneous). Its devices cite 61 predicates, 38 of them its own earlier devices. 359 recalls are linked to its devices, 63 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 Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 32009: 12010: 1
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

12in 2026

2007: 22008: 102009: 362010: 362011: 22012: 3, 1 Class I2013: 52014: 42015: 42016: 13, 7 Class I2017: 992018: 532019: 182020: 11, 8 Class I2021: 5, 4 Class I2022: 30, 29 Class I2024: 3, 2 Class I2026 (partial year): 12, 12 Class I
2007high 99 (2017) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Arrow Intl., Inc. 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?

  • DSPSystem, Balloon, Intra-Aortic And Control15decisions
  • DQYCatheter, Percutaneous11decisions
  • CAZAnesthesia Conduction Kit11decisions
  • DYBIntroducer, Catheter9decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular8decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days6decisions

Also: DQX (6), LJS (6), FMI (4), MPB (3), DRF (3), KGZ (2).

Whose devices does it build on?

Its devices cite 61 predicates; 38 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 143 times; 38 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.

  • K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 19819cite it
  • K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 19908cite it
  • K924607Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 19938cite it
  • K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 20006cite it
  • K970080Arrow-Trerotola PTD CatheterArrow Intl., Inc. · 19976cite it
  • K970229Arrow Transseptal Super Arrow-Flex Percutaneous SetArrow Intl., Inc. · 19986cite it

What has FDA decided for it lately?

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007
  • K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 200628 Class I recalls
  • K042126PICCArrow Intl., Inc. · 20041 Class I recall
  • K041153Sharpsaway II Locking Disposable CupArrow Intl., Inc. · 2004

All 110 as Arrow Intl., Inc. →

What has been recalled?

359 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
  • K003006Description/REF: PICC ACCESS TRAY/ASK-04001-CG1Apr 21, 2026Class I
  • K002507Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9…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
  • K811627Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000Apr 21, 2026Class I
  • K895417Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-FApr 21, 2026Class I

Other applicant names beginning “Arrow”

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

Arrow 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 1Arrow International, Inc. (Subsidiary of Telelflex Inc.) 1