Shockwave CS Guide Catheter

The Shockwave CS Guide Catheter is a single-lumen percutaneous catheter designed to access the coronary venous system. It can be used alone (9F) or in dual catheter delivery (e.g., 9F with 7F) and serves as a conduit for introducing interventional and diagnostic devices into the coronary venous system.

The device consists of a PTFE liner, stainless steel braid, and polymer outer jacket with transition segments that gradually decrease in stiffness from proximal to distal. It features a curved distal shaft with radiopaque tip, a standard proximal luer fitting for hemostasis valve connection, and a curve indicator providing tactile and visual cues. It is provided EO sterile for single use only.

ISO 10993-1 (biocompatibility evaluation), ISO 11135 (sterilization by ethylene oxide), and ISO 11607-1 (packaging verification). Testing included cytotoxicity, hemocompatibility, sensitization, irritation, acute systemic toxicity, and materials-mediated pyrogenicity assessments.

The Shockwave CS and predicate Boston Scientific Acuity Pro share the same intended use, sterilization method, principle of operation, and similar design features (radiopaque tip, guidewire compatibility). Minor design differences in the proximal end (no integrated hub requiring a venous access dilator) do not raise new safety or effectiveness questions. Comprehensive biocompatibility and design verification testing demonstrates the device meets all performance specifications and performs as intended, supporting substantial equivalence.