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The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria for the Cook Vascular SERPENTA™ Coronary Sinus Introducer System. The document is a 510(k) premarket notification summary from the FDA, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

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