`Predicate Devices` for medical stent

Running Head : PREDICATE DEVICES FOR MEDICAL STENT

Predicate Devices for Medical Stent

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Predicate Devices for Medical Stent

Ostial Pro Stent Positioning System

PREDICATE DEVICES

Cordis (R ) Corporation , ATWTM Marker Wire Steerable Guidewire , K994358

Lake Region Manufacturing , Inc , Coronary , Peripheral and Renal Steerable Hydrophilic Guidewire , K042338

EV3 (R ) Inc , Nitrex (R ) Guidewire , K031864

BioSphere Medical , Inc , Sequitor TM Steerable Guidewire , K061171 PORGEStm Silicone double loop ureteral stent

PREDICATE DEVICES

p PORGES ureteral stent

from BIVONA

VORTEKtm and BIOSOFTtm ureteral double loop stents

of Device The Ostial Pro Stent Positioning System is a medical grade , disposable guidewire system

The product will be used in coronary and renal stenting procedures . The product is provided sterile and intended for single use

This finished product will be compatible with 6 , 7 and 8 French catheters

tm Silicone double loop ureteral stents are supplied in kits containing the following

1 . A double loop ureteral stent and an obturator

2 . A guide-wire , where applicable

3 . A pusher (where applicable supplied with a clamp

The ureteral stent kits are supplied sterile and for single use only Functional Components Medical grade , disposable guidewire system . The product is provided sterile and intended for single use . This finished product will be compatible with 6 , 7 and 8 French catheters

A double loop ureteral stent and an obturator

A guide-wire , where applicable and

A pusher (where applicable supplied with a clamp

Principle of Operation The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures . This is a double loop ureteral stent for use in the drainage of the upper urinary tract over fistulas or ureteral obstructions (e .g . periureteral tumour cicatrisation stent management of ureteral stenoses

partial enlargement of the diameter : localized stenoses connected with ureteropelvic junction and

ureter Properties of Device Relevant to Diagnosis /Treatment

Prevention

Cure

Mitigation of Condition The device is a medical grade , disposable guidewire system This finished product will be compatible with 6 , 7 and 8 French catheters . The product will be used in coronary and renal stenting procedures . The catheter is manufactured entirely from silicone elastomer . The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent . They are steerable or non-steerable , and radiopaque . Renal and vesical loops may be either closed or open . The straight section may be partially reinforced

The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except

for the no eye on the straight section version . The ureteral stents have either a fixed core guide-wire , a movable core guide-wire or no guide-wire ,depending upon the method of use . The steerable ureteral stents have connectable pushers , and non-steerable stents have simple pushers . All these properties are relevant for its intended use as specified below

Definition of Intended Use The Ostial Pro Stent Positioning System is intended for use...