Microcatheters
PhenomTM 21 Catheter
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.
PhenomTM 21 Catheter 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 |
|---|---|---|---|
| FG13160-0615-1S | — | MR Conditional | Available |
| FG13160-0615-1S | — | MR Conditional | Available |
FDA clearances
- 510(k) K210230 February 2021
- 510(k) K151638 November 2015
Procedures that use microcatheters
Frequently asked questions
What is PhenomTM 21 Catheter 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 PhenomTM 21 Catheter?
PhenomTM 21 Catheter is made by Micro Therapeutics, Inc.. It is listed under microcatheters in our device library.
What sizes does PhenomTM 21 Catheter come in?
The FDA device database does not list sizes for PhenomTM 21 Catheter. Check the instructions for use or ask a Micro Therapeutics, Inc. representative.
Is PhenomTM 21 Catheter MRI safe?
The FDA device database lists PhenomTM 21 Catheter as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is PhenomTM 21 Catheter FDA cleared?
PhenomTM 21 Catheter is covered by FDA submissions K210230, K151638.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, 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.