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BOSS CSC, Crossing Support Catheter.

FDA UDI

Class II (US FDA UDI)

by Marvao Medical Devices, Ltd.

Identity

Trade Name
BOSS CSC, Crossing Support Catheter. FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
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 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter. FDA UDI
Model / Reference
359018150 FDA UDI
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 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter. FDA UDI

Identifiers

Catalog Number
359018150 FDA UDI
Primary DI / UDI-DI
05391525640556 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Angiographic catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Angiographic catheter, single-use

BOSS CSC, Crossing Support Catheter. by Marvao Medical Devices, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marvao Medical Devices, Ltd.

Sources (1)

  • FDA UDI 8b4ae906-25ec-4c45-ab77-3c612b6f4125 35 fields · synced Jun 8, 2026