6f MACH1 34356-xxx 5f MACH1 35845-xxx 7f MACH1 34357-xxx 8f MACH1 34358-xxx
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FDA Clearance Information
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
FDA-Cleared Indications
- Used as a catheter conduit for percutaneous vascular access during interventional procedures.
- Used to facilitate the placement and delivery of other interventional devices or therapeutic agents.
- Intended for use by trained clinicians in procedures requiring catheter-based access to the vascular system.
Clinical Applications
- Providing catheter access during percutaneous vascular interventions.
- Supporting delivery of compatible interventional devices to a selected vascular location.
- Facilitating catheter-based procedures in interventional cardiology and interventional radiology settings.
- Providing access for procedures involving treatment or evaluation of the venous system when consistent with the applicable device labeling.
Reported off-label uses
- Use as a support or delivery catheter during selected venous thrombectomy procedures may occur in clinical practice, depending on anatomy, device compatibility, and operator judgment.
- Use during selected venous stent-delivery procedures may occur beyond the specific wording of the device summary, subject to institutional policy and clinician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Available configurations listed in this record include 5F, 6F, 7F, and 8F sizes; the appropriate French size depends on the required device compatibility, access site, anatomy, and procedural plan.
- Confirm compatibility with guidewires, sheaths, stents, thrombectomy systems, contrast agents, and other devices before use.
- Catheter advancement should be performed under appropriate imaging guidance by clinicians trained in vascular catheterization.
- The provided FDA record does not establish MRI safety status; review the current manufacturer labeling for MR Safe, MR Conditional, or MR Unsafe conditions before MRI.
- Contraindications, warnings, storage requirements, and handling instructions should be checked in the current instructions for use. The device is not intended for unsupervised or nonclinical use.
Procedures that use this device
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.