510(k) Report

FDA applicant

Cook Vascular, Inc.

Vandergrift, PA12 decisions2001–20141 recall

FDA records 12 decisions for Cook Vascular, Inc. (Vandergrift, PA) from 2001 to 2014: 12 510(k) clearances. Most are in product codes DRE (Dilator, Vessel, For Percutaneous…) and DYB (Introducer, Catheter). Its devices cite 9 predicates, 3 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, cardiovascular panel, where it files most

How often FDA has decided Cook Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2008: 12009: 12011: 12014: 2
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cook Vascular, Inc.’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?

  • DREDilator, Vessel, For Percutaneous Catheterization4decisions
  • DYBIntroducer, Catheter2decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions
  • FPASet, Administration, Intravascular1decision
  • DPWFlowmeter, Blood, Cardiovascular1decision
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision

Also: GEI (1).

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 3 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.

  • K061000Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 20063cite it
  • K141148Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath…Cook Vascular, Inc. · 20142cite it
  • K010128Cook Vascular Peel-Away Hemostasis ValveCook Vascular, Inc. · 20022cite it
  • K081425Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable PortCook Vascular, Inc. · 20082cite it
  • K022649Cook-Swartz Doppler Flow ProbeCook Vascular, Inc. · 20021cites it

What has FDA decided for it lately?

  • K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath…Cook Vascular, Inc. · 2014
  • K141148Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath…Cook Vascular, Inc. · 2014
  • K110347Doppler MonitorCook Vascular, Inc. · 2011
  • K083482Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc. · 2009
  • K081425Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable PortCook Vascular, Inc. · 20081 recall
  • K061000Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
  • K032223Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation SwitchCook Vascular, Inc. · 2003
  • K023937Cook Vascular Serpenta Coronary Sinus Introducer SystemCook Vascular, Inc. · 2003

All 12 as Cook Vascular, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081425Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port…Nov 28, 2017Class II

Other applicant names beginning “Cook”

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

Cook, Inc. 371Cook Urological, Inc. 104Cook Biotech, Inc. 47Cook Ob/Gyn 43Cook Ireland, Ltd. 37Cook Pacemaker Corp. 35Cook Endoscopy 5Cook Biotech Incorprated 4Cook Medical Incorporated 3Cook (Canada), Inc. 1Cook Advanced Technologies 1Cook Corporated 1