đź“‹ FDA Reference

AngioDynamics Soft-Vu Hydrophilic Coated Angiographic Catheter

AngioDynamics, Inc.

Contact a rep Compare similar devices

Summary: The Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter is a medical device used for angiographic procedures to visualize blood vessels. It is primarily used by interventional radiologists and cardiologists.

FDA Clearance Information

Pathway ? 510(k)
Number ? K001578 ↗
Decision Date ? October 13, 2000
Product Code ? DQO Catheter, Intravascular, Diagnostic
Device Class ? Class 2
Evidence ? 419 studies

The Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter was cleared through the FDA 510(k) pathway on October 13, 2000. It is manufactured by Angiodynamics and classified as a Class 2 medical device.

What It Is

This device is a hydrophilic coated angiographic catheter designed to facilitate the visualization of blood vessels during angiographic procedures. The hydrophilic coating reduces friction, allowing for smoother navigation through the vascular system. It is typically used in conjunction with imaging techniques to deliver contrast agents, enabling detailed visualization of vascular structures.

FDA-Cleared Indications

  • Use in procedures requiring visualization of blood vessels during angiography.
  • Delivery of contrast material to selected blood vessels for diagnostic imaging.

Clinical Applications

  • Diagnostic angiography to evaluate the size, shape and patency of blood vessels.
  • Selective catheterization of blood vessels for contrast injection.
  • Vascular imaging during interventional procedures when angiographic visualization is required.

Practical Considerations

  • Available catheter sizes, lengths and tip configurations should be selected according to the target vessel, access site and procedure.
  • The hydrophilic coating is activated with sterile fluid and requires careful handling to avoid damaging the coating.
  • The catheter is used with compatible guidewires, contrast injectors and angiography equipment according to the product instructions.
  • MRI safety depends on the specific catheter model and labeling; the device should not be assumed to be MRI safe without reviewing current manufacturer instructions.
  • Contraindications and precautions include known allergies to catheter materials or contrast media, vascular injury risk and inability to safely access the intended vessel.

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 Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter used for?

It is used for visualizing blood vessels during angiographic procedures, often in diagnostic and therapeutic contexts.

What specialties typically use this device?

Interventional radiologists and cardiologists primarily use this device.

What are the FDA-cleared indications?

The device is indicated for use in procedures requiring blood vessel visualization, such as diagnostic angiography and embolization.

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.

📬 The IR Device Brief

One email a month: new FDA clearances, recalls and device pages in vascular & interventional radiology.

We'll email you a link to confirm. Unsubscribe any time.

Suggest edits

For manufacturers and their teams. Each field shows what the page says now: add, remove or rewrite anything, and leave the rest as is. LA Vascular reviews every change before it goes live.

About you