Shockwave Medical Shockwave C2 Coronary Intravascular lithotripsy (IVL) System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

QUALTECH CONSULTING CORPORATION PTE. LTD.

Class:

Class D medical device

Manufactured by:

Shockwave Medical, Inc.

Therapeutic area:

Cardiovascular

Therapeutic indications:

The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.”

Product summary:

Models: Shockwave C2 Coronary Intravascular Lithotripsy Catheter - C2IVL2512, Shockwave C2 Coronary Intravascular Lithotripsy Catheter - C2IVL3012, Shockwave C2 Coronary Intravascular Lithotripsy Catheter - C2IVL3512, Shockwave C2 Coronary Intravascular Lithotripsy Catheter - C2IVL4012, Shockwave Intravascular Lithotripsy Generator and Connector Cable - IVLGCC, Shockwave Intravascular Lithotripsy Generator and Connector Cable - IVLGCCD, Intravascular Lithotripsy Connector Cable - IVLCC

Authorization date:

2020-11-19