📋 FDA Reference
Scimed Viper PTA Catheter with Bioslide Hydrophilic Coating
Scimed Peripheral Interventions
Summary: The Scimed Viper PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is typically used by interventional radiologists and vascular surgeons to treat vascular conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K935501 ↗
Decision Date ?
January 27, 1994
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class ?
Class 2
Evidence ?
419 studies
The Scimed Viper PTA Catheter received FDA clearance through the 510(k) pathway on January 27, 1994. It is manufactured by Scimed Peripheral Interventions and classified as a Class 2 medical device.
What It Is
The Scimed Viper PTA Catheter is a balloon catheter designed for use in percutaneous transluminal angioplasty (PTA) procedures. It features a hydrophilic coating known as BioSlide, which reduces friction during insertion and navigation through blood vessels. This device is used to dilate narrowed or obstructed blood vessels, improving blood flow and alleviating symptoms associated with vascular diseases.
FDA-Cleared Indications
- Angioplasty of stenotic or obstructed peripheral blood vessels.
- Percutaneous transluminal dilation of peripheral arterial lesions using balloon catheter technology.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of peripheral arterial obstructions in the lower extremities.
- Dilation of atherosclerotic peripheral arterial lesions.
- Use during catheter-based peripheral vascular interventions in adults.
Practical Considerations
- The catheter should be selected according to the target vessel diameter, lesion characteristics, and the available balloon dimensions.
- Use requires compatible guidewires, introducer sheaths, and angiographic imaging equipment according to the device labeling and institutional practice.
- The hydrophilic coating should be kept properly hydrated during preparation and use; follow the manufacturer's instructions for handling and advancement.
- As with peripheral angioplasty catheters generally, risks include vessel dissection or perforation, thrombosis, embolization, bleeding at the access site, infection, and contrast-related complications.
- MRI safety information is not established in the provided FDA record. MRI conditions should be confirmed in the current manufacturer labeling before scanning a patient with the device in place.
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
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 Scimed Viper PTA Catheter used for?
It is used for performing percutaneous transluminal angioplasty to treat narrowed or blocked blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in angioplasty procedures to treat peripheral arterial disease and other vascular obstructions.
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.