Microcatheters
PX400 Microcatheter
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
PX400 Microcatheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| PX400J-A | — | Not stated | Available |
| PX400STR-A | — | Not stated | Available |
| PX40045-A | — | Not stated | Available |
| PX40090-A | — | Not stated | Available |
FDA clearances
- 510(k) K100826 July 2010
Procedures that use microcatheters
Frequently asked questions
What is PX400 Microcatheter used for?
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Who makes PX400 Microcatheter?
PX400 Microcatheter is made by Penumbra, Inc.. It is listed under microcatheters in our device library.
What sizes does PX400 Microcatheter come in?
The FDA device database does not list sizes for PX400 Microcatheter. Check the instructions for use or ask a Penumbra, Inc. representative.
Is PX400 Microcatheter MRI safe?
The FDA device database entry for PX400 Microcatheter does not state its MRI safety status. Check the labeling before MRI.
Is PX400 Microcatheter FDA cleared?
PX400 Microcatheter is covered by FDA submission K100826.
How do I contact a Penumbra, Inc. sales representative?
Penumbra, Inc. has not listed representatives on LA Vascular yet. Visit the Penumbra, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.