đź“‹ FDA Reference
6f mach1 34356-xxx 5f mach1 35845-xxx 7f mach1 34357-xxx 8f mach1 34358-xxx
Boston Scientific
Summary: The Mach1 Guide Catheters by Boston Scientific are used in interventional cardiology and radiology for accessing the venous system. These devices are primarily utilized by cardiologists and radiologists to facilitate the placement of other devices or medications.
FDA Clearance Information
Pathway
510K
Number
K020028 ↗
Decision Date
January 22, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Mach1 Guide Catheters received FDA clearance through the 510(k) pathway on January 22, 2002. Manufactured by Boston Scientific, these devices are classified as Class 2 under product code DQY.
What It Is
The Mach1 Guide Catheters are medical devices designed to provide a conduit for the delivery of interventional tools into the venous system. These catheters are flexible, allowing for navigation through the vascular anatomy to reach target sites. They are essential in procedures that require precise placement of stents or other therapeutic devices.
Clinical Applications
Mach1 Guide Catheters are commonly used in interventional cardiology and radiology procedures. They are particularly useful in settings like cardiac catheterization labs and interventional radiology suites. These devices are used for patients requiring venous stenting or other interventions that necessitate vascular access.
Indications for Use
The FDA-cleared indications for the Mach1 Guide Catheters include use in procedures requiring venous access for stent placement. They are suitable for patients with conditions necessitating the reinforcement of venous structures.
Practical Considerations
These guide catheters come in various sizes, such as 5F, 6F, 7F, and 8F, to accommodate different patient anatomies and procedural needs. Compatibility with other interventional devices should be verified prior to use, and clinicians should be skilled in catheter navigation techniques.
Frequently Asked Questions
What is Mach1 Guide Catheters used for?
Mach1 Guide Catheters are used for providing access to the venous system to facilitate the placement of stents or other therapeutic devices.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use Mach1 Guide Catheters in procedures requiring vascular access.
What are the FDA-cleared indications?
The FDA-cleared indications include use in procedures requiring venous access for stent placement in patients with venous conditions.
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.