đź“‹ FDA Reference

flexor radial hydrophilic introducer access set

Cook

Summary: The Flexor Radial Hydrophilic Introducer Access Set is a medical device used to facilitate vascular access during interventional procedures. It is primarily used by interventional radiologists and cardiologists.

FDA Clearance Information

Pathway 510K
Decision Date October 9, 2014
Product Code DYB
Device Class Class 2
Evidence 419 studies

The Flexor Radial Hydrophilic Introducer Access Set by Cook was cleared through the FDA 510k pathway on October 9, 2014. It is a Class 2 medical device under product code DYB.

What It Is

The Flexor Radial Hydrophilic Introducer Access Set is designed to provide a conduit for the introduction of catheters and other devices into the vascular system. It features a hydrophilic coating that reduces friction, facilitating smoother insertion and navigation through blood vessels. This device is particularly useful in procedures requiring radial artery access, offering enhanced control and precision.

Clinical Applications

Commonly used in interventional radiology and cardiology, this device is employed in procedures such as angiography, embolization, and other endovascular interventions. It is particularly beneficial in settings where radial artery access is preferred, such as in patients with peripheral vascular disease or when femoral access is contraindicated. The device is suitable for adult patients requiring vascular interventions.

Indications for Use

The FDA indications for this device include its use in procedures involving embolization coils and liquid agents. It is intended for patients needing vascular access for diagnostic or therapeutic interventions, particularly when radial access is advantageous.

Practical Considerations

The Flexor Radial Hydrophilic Introducer Access Set comes in various sizes to accommodate different patient anatomies and procedural requirements. Its hydrophilic coating requires activation with saline to ensure optimal performance. Clinicians should be familiar with radial access techniques for effective use.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

View Source →
PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

View Source →
PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

View Source →
PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

View Source →
PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

View Source →
PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

View Source →
PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is the Flexor Radial Hydrophilic Introducer Access Set used for?

It is used to facilitate vascular access during interventional procedures, such as angiography and embolization.

What specialties typically use this device?

Interventional radiologists and cardiologists commonly use this device.

What are the FDA-cleared indications?

The device is indicated for use in procedures involving embolization coils and liquid agents, providing vascular access for diagnostic or therapeutic interventions.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.