đź“‹ FDA Reference
Impress Angiographic Catheter with Hydrophilic Coating
Summary: The impress angiographic catheter with hydrophilic coating is a medical device used in angiographic procedures to deliver contrast media. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093004 ↗
Decision Date ?
February 12, 2010
Product Code ?
DQO Catheter, Intravascular, Diagnostic
Device Class ?
Class 2
Evidence ?
419 studies
The impress angiographic catheter was cleared through the FDA 510k pathway on February 12, 2010. It is manufactured by Merit Medical Systems and is classified as a Class 2 device.
What It Is
The impress angiographic catheter is a flexible tube with a hydrophilic coating designed to facilitate the delivery of contrast media during angiographic procedures. The hydrophilic coating reduces friction, allowing for smoother navigation through blood vessels. This device is essential in obtaining clear imaging of blood vessels for diagnostic and interventional purposes.
FDA-Cleared Indications
- Delivery of contrast media into blood vessels during angiographic procedures.
- Visualization of the vasculature for diagnostic or interventional imaging.
Clinical Applications
- Peripheral angiography to image arteries in the limbs and other peripheral vessels.
- Coronary angiography to deliver contrast media for imaging the coronary arteries.
- Neuroangiography to deliver contrast media for imaging vessels supplying the brain.
- Angiographic imaging performed in patients who require detailed vascular evaluation.
Practical Considerations
- The catheter is available in different sizes and configurations; selection depends on the access site, target vessel, anatomy and compatible guidewire or sheath.
- The hydrophilic coating should be activated and kept wet with sterile saline according to the manufacturer's instructions.
- Confirm compatibility with the guidewire, introducer sheath, injection system and contrast medium before use.
- Use requires appropriate vascular access, imaging guidance and trained personnel. Potential contraindications and warnings include allergy to contrast media, infection at the access site, significant bleeding risk and vessel injury risk.
- MRI safety depends on the specific catheter model and whether it remains in the patient. Check the current manufacturer labeling before MRI; do not assume the device is MRI safe.
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 impress angiographic catheter used for?
It is used to deliver contrast media for imaging blood vessels during angiographic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for delivering contrast media to visualize blood vessels during angiographic procedures.
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.