đź“‹ FDA Reference
Primum Hydrophilic Guiding Catheter
Pendracare
Summary: The primum hydrophilic guiding catheter by Pendracare is a medical device used in vascular procedures to guide other instruments. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K250972 ↗
Decision Date ?
June 29, 2025
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
419 studies
The primum hydrophilic guiding catheter was cleared via the FDA 510k pathway on June 29, 2025. Manufactured by Pendracare, it is classified as a Class 2 device under product code DQY.
What It Is
The primum hydrophilic guiding catheter is a flexible tube designed to navigate through blood vessels. Its hydrophilic coating allows for smoother passage through the vasculature, reducing friction and improving maneuverability. This device is crucial in procedures requiring precise placement of other instruments, such as stents or embolization agents.
FDA-Cleared Indications
- Use during percutaneous vascular procedures to guide other interventional devices.
- Use for placement of venous stents.
- Use for administration or delivery of embolization agents.
Clinical Applications
- Guiding instruments during percutaneous venous interventions.
- Supporting delivery and placement of venous stents.
- Delivering liquid embolization agents during indicated vascular procedures.
Practical Considerations
- Available catheter sizes and configurations should be selected for the target vessel, access route and device being delivered.
- The hydrophilic coating should be prepared and kept wet according to the manufacturer’s instructions to reduce friction during advancement.
- The catheter is intended for use with compatible guidewires and other devices; compatibility should be confirmed before the procedure.
- It should be used by clinicians trained in endovascular techniques, with imaging guidance and appropriate anticoagulation or flushing protocols when indicated.
- MRI safety information is device-specific. Confirm the manufacturer’s labeling before an MRI examination; do not assume the catheter is MR Safe or MR Conditional.
Procedures that use this device
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 primum hydrophilic guiding catheter used for?
It is used to guide other instruments in vascular procedures, such as placing stents or delivering embolization agents.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures involving venous stents and embolization 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.