📋 FDA Reference
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Product: Advance Serenity 18 — all models and sizes · Where to buy · Find similar PTA balloons by size
Summary: The 018 hydrophilic coated OTW PTA balloon dilatation catheter is a medical device used for percutaneous transluminal angioplasty procedures. It is typically used by interventional radiologists and vascular surgeons to treat vascular obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180007 ↗
Decision Date ?
April 19, 2018
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on April 19, 2018. Manufactured by Creagh Medical, it is classified as a Class 2 device under product code LIT.
What It Is
The 018 hydrophilic coated OTW PTA balloon dilatation catheter is designed for use in percutaneous transluminal angioplasty (PTA) to dilate stenotic segments of blood vessels. It features a hydrophilic coating that reduces friction, facilitating smoother navigation through the vasculature. The catheter is over-the-wire (OTW), allowing for precise placement and control during procedures.
FDA-Cleared Indications
- Dilation of stenotic segments in peripheral blood vessels to improve blood flow.
- Percutaneous transluminal angioplasty of narrowed vessels using an over-the-wire balloon catheter.
Clinical Applications
- Balloon angioplasty of peripheral arterial stenoses.
- Treatment of narrowed lower-extremity arteries when vessel dilation is indicated.
- Dilation of stenotic renal or other peripheral arteries within the device labeling.
- Use over a compatible guidewire during image-guided endovascular angioplasty.
Practical Considerations
- The catheter is available in balloon diameters and lengths selected to match the target vessel and stenotic segment.
- It is an over-the-wire device and requires a compatible guidewire, introducer sheath, and access system.
- The hydrophilic coating should be kept wet according to the instructions for use to reduce friction during advancement.
- MRI safety depends on the specific device labeling and implanted or retained components; the catheter is generally removed after angioplasty, so MRI conditions should be confirmed before scanning.
- Contraindications and precautions include inability to cross the lesion safely, severe vessel injury risk, uncorrected bleeding disorders, and allergy or intolerance to materials or contrast media when applicable.
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 018 hydrophilic coated OTW PTA balloon dilatation catheter used for?
It is used for dilating stenotic segments of blood vessels during percutaneous transluminal angioplasty procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the dilation of stenotic segments in blood vessels to improve blood flow, particularly in patients with peripheral artery disease.
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.