đź“‹ FDA Reference

micra introducer sheath with hydrophilic coating

Medtronic

Summary: The Micra Introducer Sheath with hydrophilic coating is a medical device used primarily by interventional cardiologists for the delivery of embolization devices. It is designed to facilitate the introduction of catheters into the vascular system.

FDA Clearance Information

Pathway 510K
Decision Date September 27, 2013
Product Code DYB
Device Class Class 2
Evidence 419 studies

The Micra Introducer Sheath was cleared through the FDA 510(k) pathway on September 27, 2013. Manufactured by Medtronic, it is classified as a Class 2 device under product code DYB.

What It Is

The Micra Introducer Sheath is a specialized medical device featuring a hydrophilic coating, which reduces friction and facilitates smoother insertion into the vascular system. It is used to introduce catheters and other devices into the body, particularly during procedures that require precise vascular access. The hydrophilic coating enhances maneuverability and reduces the risk of vascular trauma.

Clinical Applications

This device is commonly used in interventional cardiology and radiology for procedures involving embolization, where precise delivery of coils or liquid agents is necessary. It is particularly useful in settings such as cardiac catheterization labs and interventional radiology suites. The sheath is designed for use in adult patients requiring vascular access for therapeutic interventions.

Indications for Use

The Micra Introducer Sheath is indicated for use in patients requiring vascular access for the delivery of embolization devices. It is suitable for conditions where embolization is needed to block abnormal blood flow or to deliver therapeutic agents.

Practical Considerations

The sheath typically comes in various sizes to accommodate different patient anatomies and procedural requirements. Its hydrophilic coating requires activation with saline to ensure optimal performance. Clinicians should be familiar with the technique of sheath insertion and the compatibility with other devices used during 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

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 Micra Introducer Sheath used for?

It is used for the introduction of catheters and embolization devices into the vascular system, primarily in interventional cardiology and radiology.

What specialties typically use this device?

Interventional cardiologists and radiologists commonly use this device during procedures that require vascular access.

What are the FDA-cleared indications?

The device is indicated for use in patients requiring vascular access for the delivery of embolization devices, such as coils or liquid agents.

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.

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