đź“Š Evidence-Based Reference
pacepath model 819
Pacesetter Systems
Summary: The Pacepath Model 819 is a medical device by Pacesetter Systems, cleared by the FDA for clinical use. It is primarily used in the context of IVC filters. Key evidence includes 10 linked studies, although none directly relate to this device.
FDA Clearance Information
Pathway
510K
Number
K801417 ↗
Decision Date
October 23, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacepath Model 819 was cleared through the FDA 510(k) pathway on October 23, 1980, by Pacesetter Systems. It is classified as a Class 3 device under product code DTB.
What It Is
The Pacepath Model 819 is a clinician-facing device designed for use in the context of inferior vena cava (IVC) filters. It is intended to assist in the management of conditions requiring IVC filtration.
Clinical Applications
Common clinical scenarios for the Pacepath Model 819 include its use in patients requiring IVC filtration to prevent pulmonary embolism. It is typically used in settings where anticoagulation therapy is contraindicated.
Evidence Summary
The available literature includes 10 studies, though none specifically address the Pacepath Model 819. The studies span various topics and methodologies, with publication years ranging from 2023 to 2025.
Reported Outcomes
Published studies report various outcomes related to genetic polymorphisms, cancer associations, and imaging techniques. However, none of these studies directly evaluate the efficacy of the Pacepath Model 819.
Safety Profile
Reported complications include general findings from the studies, such as genetic predispositions to certain cancers. No specific safety data is available for the Pacepath Model 819.
Evidence Limitations
The evidence lacks direct studies on the Pacepath Model 819, highlighting a gap in device-specific research. Further investigation is needed to assess its clinical efficacy and safety.
Frequently Asked Questions
What are the clinical indications for Pacepath Model 819?
Refer to FDA documentation for specific indications related to IVC filter use.
What outcomes have been reported in clinical studies?
The linked studies report outcomes on genetic polymorphisms and cancer, but not directly on the device.
What complications have been reported?
Safety data from the studies include general genetic and cancer-related findings, not specific to the device.
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.