Trade Resources Industry Views The US FDA Has Granted 510(K) Clearance to Teleflex's Arrow VPS G4 Device

The US FDA Has Granted 510(K) Clearance to Teleflex's Arrow VPS G4 Device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ARROW VPS G4 device.

Used in conjunction with the accompanying disposable ARROW VPS Stylet, the device uses micro-Doppler ultrasound technology along with intravascular ECG and advanced algorithms to locate the exact location of the lower 1/3 of the superior vena cava and cavo-atrial junction, the ideal location for the tip of a PICC.

The device also provides clinicians with real time information, which can enable avoidance of potentially serious clinical complications such as thrombosis, arterial puncture and vessel wall damage.

Teleflex vascular division president Paul Molloy said the easy-to-use system also helps to reduce complications and reduce patient exposure to radiation.

"If used on a regular basis, the system can help streamline hospital workflow, providing benefits to the patient, the caregiver and the health care system," Molloy added.

"This new product introduction complements our full portfolio aimed at making zero complications in vascular access a reality."

Teleflex said the device will be available in the US in Q2 2013.

 

 

Source: http://cardiovasculardevices.medicaldevices-business-review.com/news/fda-approves-teleflex-arrow-vps-g4-device-300413
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FDA Approves Teleflex ARROW VPS G4 Device