📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Embolization or occlusion of selected blood vessels during an interventional procedure.
- Use as an embolic agent to block blood flow to a targeted vascular region.
Clinical Applications
- Catheter-directed embolization of selected blood vessels.
- Control of bleeding when vessel occlusion is clinically indicated.
- Reduction of blood flow to a targeted vascular region as part of an interventional procedure.
Practical Considerations
- The lyophilized material must be reconstituted according to the applicable product labeling and institutional protocol before administration.
- The operator should confirm compatibility with the delivery catheter, needles, contrast media and other embolization equipment before use.
- The appropriate formulation and volume depend on the target vessel, desired degree of occlusion and procedural technique.
- Contraindications, preparation requirements, storage conditions and handling precautions should be checked in the current manufacturer labeling.
- MRI safety cannot be determined from the available FDA record alone; the reconstituted agent, vial materials and any implanted or retained delivery components should be evaluated separately.
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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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
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Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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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 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.