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BOSS CSC, Crossing Support Catheter.

MARVAO MEDICAL DEVICES LIMITED · Model 180000135 · UDI-DI 05391525640914

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/135cm length catheter packaged individually.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.