(93 days)
The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.
This is a 510(k) premarket notification for a medical device called "Breezeway II," a catheter introducer. The document details the device's characteristics and how it compares to a predicate device ("Adelante Breezeway Delivery Sheath," K122958) to demonstrate substantial equivalence, rather than a study proving the device meets an acceptance criteria for an AI/ML powered device. Therefore, it is impossible to provide the requested information.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).