đź“‹ FDA Reference
lyophilized vials of vca and vcat
Gibco Laboratories Life Technologies
Summary: Lyophilized vials of VCA and VCAT are embolization liquid agents used primarily in interventional radiology to occlude blood vessels. They are typically used by interventional radiologists in procedures to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K780306 ↗
Decision Date
March 17, 1978
Product Code
JSK
Device Class
Class 1
Evidence
419 studies
This device was cleared through the FDA 510k pathway on March 17, 1978. Manufactured by Gibco Laboratories Life Technologies, it is classified as a Class 1 device under product code JSK.
What It Is
Lyophilized vials of VCA and VCAT are embolization agents used to occlude blood vessels. These agents are typically reconstituted into a liquid form before use. They are designed to block blood flow to specific areas, which can be useful in treating vascular malformations or controlling bleeding.
Clinical Applications
These embolization agents are commonly used in interventional radiology, particularly in procedures involving the occlusion of abnormal blood vessels. They are used in settings such as hospitals and specialized clinics, often for patients with arteriovenous malformations or tumors that require reduced blood supply. The agents are also used in emergency settings to control hemorrhages.
Indications for Use
The FDA indications suggest that these agents are intended for use in embolization procedures. Clinically, this means they are used to block blood flow in patients with conditions like vascular malformations or to control bleeding in trauma cases.
Practical Considerations
These vials are typically available in various sizes to accommodate different procedural needs. They require careful handling and precise reconstitution before use. Compatibility with other embolization tools and techniques should be considered to ensure optimal outcomes.
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
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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
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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
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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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 lyophilized vials of VCA and VCAT used for?
They are used for embolization procedures to occlude blood vessels in the treatment of vascular abnormalities and to control bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these embolization agents.
What are the FDA-cleared indications?
These agents are indicated for use in embolization procedures to block blood flow in conditions like vascular malformations or to control bleeding.
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.