Microcatheters
M-CATH Flexy
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
M-CATH Flexy 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 |
|---|---|---|---|
| 820135732 | Length 135 cm | Not stated | Available |
| 820150732 | Length 150 cm | Not stated | Available |
FDA clearances
- 510(k) K171176 September 2017
Procedures that use microcatheters
Frequently asked questions
What is M-CATH Flexy used for?
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Who makes M-CATH Flexy?
M-CATH Flexy is made by Acrostak (Schweiz) AG. It is listed under microcatheters in our device library.
What sizes does M-CATH Flexy come in?
Sizes listed for M-CATH Flexy: Length: 135–150 cm. Confirm availability with the manufacturer's instructions for use.
Is M-CATH Flexy MRI safe?
The FDA device database entry for M-CATH Flexy does not state its MRI safety status. Check the labeling before MRI.
Is M-CATH Flexy FDA cleared?
M-CATH Flexy is covered by FDA submission K171176.
How do I contact a Acrostak (Schweiz) AG sales representative?
Acrostak (Schweiz) AG has not listed representatives on LA Vascular yet. Visit the Acrostak (Schweiz) AG 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.