đź“‹ FDA Reference
orchestra hydrophilic guidewire standard angled orchestra hydrophilic guidewire straight stiff orchestra hydrophilic guidewire angled stiff orchestra hydrophilic guidewire standard straight orchestra hydrophilic guidewire straight stiff
Coloplast A/S
Summary: The Orchestra Hydrophilic Guidewire is a versatile device used in vascular procedures to navigate through blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K150927 ↗
Decision Date
May 27, 2015
Product Code
OCY
Device Class
Class 2
Evidence
419 studies
The Orchestra Hydrophilic Guidewire by Coloplast A/S was cleared through the FDA 510(k) pathway on May 27, 2015. It is a Class 2 medical device under product code OCY.
What It Is
The Orchestra Hydrophilic Guidewire is a medical device designed to assist in navigating through the vascular system during procedures. It features a hydrophilic coating that reduces friction, allowing for smoother passage through blood vessels. The guidewire comes in various configurations, including standard and stiff, with angled or straight tips, to accommodate different procedural needs.
Clinical Applications
This guidewire is commonly used in interventional radiology and vascular surgery for procedures such as angioplasty, stent placement, and embolization. It is particularly useful in navigating tortuous or narrow vessels, making it suitable for patients with complex vascular anatomies. The device is typically used in hospital settings, including catheterization labs and operating rooms.
Indications for Use
The FDA indications suggest that this guidewire is intended for use in procedures requiring the navigation of blood vessels, such as during the delivery of embolization agents. It is suitable for patients needing vascular interventions.
Practical Considerations
The Orchestra Hydrophilic Guidewire is available in various lengths and diameters to suit different procedural requirements. It is compatible with a range of catheters and should be selected based on the specific clinical scenario. Proper technique in handling and insertion is crucial to avoid vessel damage.
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 Orchestra Hydrophilic Guidewire used for?
It is used to navigate through blood vessels during vascular procedures such as angioplasty and embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The guidewire is indicated for use in navigating blood vessels during procedures involving embolization 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.