đź“‹ FDA Reference
014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Product: Advance Serenity 14 — all models and sizes
Summary: The 014 hydrophilic coated PTA balloon dilatation catheter is a medical device used for percutaneous transluminal angioplasty procedures. It is primarily used by interventional radiologists and cardiologists to treat vascular conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171251 ↗
Decision Date ?
September 8, 2017
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class ?
Class 2
Evidence ?
419 studies
The 014 hydrophilic coated PTA balloon dilatation catheter was cleared through the FDA 510k pathway on September 8, 2017. It is manufactured by Creagh Medical and classified as a Class 2 device under product code LIT.
What It Is
The 014 hydrophilic coated PTA balloon dilatation catheter is a specialized catheter used in angioplasty procedures to dilate narrowed or obstructed blood vessels. It features a hydrophilic coating that reduces friction, facilitating smoother navigation through the vascular system. The balloon is inflated at the target site to compress plaque against the vessel wall, improving blood flow.
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of stenotic or obstructed peripheral arteries.
- Dilatation of peripheral vascular lesions using balloon inflation at the treatment site.
- Use in adult patients whose peripheral arteries require catheter-based vessel dilation, according to the device labeling.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of peripheral arterial stenoses or obstructions during a catheter-based procedure.
- Dilation of a target peripheral vascular lesion after crossing it with a guidewire.
- Use in catheterization laboratories by trained clinicians during image-guided peripheral vascular intervention.
Practical Considerations
- The 0.014-inch profile is intended for navigation over a compatible guidewire and through appropriately sized catheter systems.
- The hydrophilic coating generally requires activation with sterile saline according to the instructions for use; the catheter should not be advanced without appropriate lubrication.
- The balloon size, shaft length, guidewire compatibility, inflation medium, and rated burst pressure must match the target vessel and procedure.
- Use requires fluoroscopic imaging and careful balloon inflation to reduce the risk of dissection, perforation, embolization, thrombosis, or vessel injury.
- MRI safety depends on the specific catheter and whether it remains in the body; the product labeling should be checked, and temporary angioplasty catheters are generally removed after the procedure.
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 014 hydrophilic coated PTA balloon dilatation catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or blocked blood vessels, improving blood flow.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for percutaneous transluminal angioplasty to treat vascular conditions causing narrowed or obstructed arteries.
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.