General DeVoro
Where is the DeVoro site located?
Fremont, CA
What is the French size of the Venous catheter?
14F
What are the rings on the SC outer shaft used for?
They are length markers, however they are not necessary due to the radiopacity of the basket and will be removed from the design.
Which section of the QMS is this team responsible for during integration?
Production and Process Controls (P&PC)
Inverted WOLF creates FLOW
What are the 4 venous funnel sizes available for use?
6mm, 8mm, 10mm, 12mm
True or false. SmartClaw must be used in every case.
False, SmartClaw is an accessory that can be used if needed to break apart clot but is not required.
What type of document defines integration strategy for our team?
P&PC PTP
Venous, Arterial, PE
How many inners are in a reload pack?
There are 2 options, a single reload and a triple reload.
How many basket sizes do we have for SmartClaw and what are they?
2 sizes: 20mm and 32mm
List 2 high level PD deliverables that must occur for each process.
Process characterization, work instructions, PRA, TMV, OQ/PQ protocol and report, EQ
How many sites has the DeVoro team occupied in CA?
True or false. All funnel sizes contain a force fiber ring.
False, 6mm has no force fiber ring.
How many different names has SmartClaw had?
3: WolfTrap, WolfXB, and SmartClaw
Name at least 2 key stakeholders (excluding the vendor) involved in a successful FAT.
EEG, PD, ME, QE
Where does the name Devoro come from?
It's the latin word for Devour
What is the purpose of the puller accessory?
To aid in removal of the inner during a procedure by increasing ability to grip the shaft.
What was the name for the device that was turned down by marketing?
WolfTrap due to the potential to confuse it with animal traps!
Which products previously occupied the ISO 8 and CNC spaces that will be the new home of WOLF?
Watchman and High Torque Sleeve