đź“‹ FDA Reference
stryker drop applicator kits spray applicator kit tips
Stryker
Summary: The Stryker Drop Applicator Kits are medical devices used for the precise application of therapeutic agents in portal vein procedures. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K950824 ↗
Decision Date
August 25, 1995
Product Code
FMF
Device Class
Class 2
Evidence
0 studies
The Stryker Drop Applicator Kits were cleared through the FDA 510(k) pathway on August 25, 1995. Manufactured by Stryker, this Class 2 device falls under the product code FMF.
What It Is
The Stryker Drop Applicator Kits are specialized devices designed to facilitate the application of therapeutic agents, such as hemostatic or adhesive solutions, in medical procedures involving the portal vein. These kits typically include spray applicator tips that allow for controlled and precise delivery of substances, minimizing waste and enhancing procedural accuracy. The device is particularly useful in complex vascular procedures where precision is critical.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Stryker Drop Applicator Kits are employed in procedures involving the portal vein, such as embolization or sclerotherapy. They are suitable for use in hospital settings, particularly in operating rooms and interventional suites. The device is beneficial for adult patients undergoing procedures that require precise delivery of therapeutic agents to the portal vein.
Indications for Use
The FDA-cleared indications for the Stryker Drop Applicator Kits involve their use in procedures requiring the application of agents to the portal vein. This includes conditions where controlled delivery of substances is necessary for therapeutic effect or procedural success.
Practical Considerations
The Stryker Drop Applicator Kits are available in various sizes to accommodate different procedural needs. They are compatible with standard catheter systems used in portal vein interventions. Clinicians should be familiar with the specific technique for using spray applicator tips to ensure optimal results.
Frequently Asked Questions
What is the Stryker Drop Applicator Kits used for?
The Stryker Drop Applicator Kits are used for the precise application of therapeutic agents in portal vein procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the application of agents to the portal vein.
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.