ENDOCROSS Device ENDOCROSS

GUDID 00860008946409

The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.

PQ Bypass, Inc.

Vascular guide-catheter, single-use
Primary Device ID00860008946409
NIH Device Record Keybd08aee8-8deb-46b9-b11a-cb97942109bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOCROSS Device
Version Model NumberENDOCROSS
Catalog NumberENDOCROSS
Company DUNS050620329
Company NamePQ Bypass, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008946409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWMStent Graft, Bypass, Superficial Femoral Artery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

Devices Manufactured by PQ Bypass, Inc.

00860008946409 - ENDOCROSS Device2023-09-08The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
00860008946409 - ENDOCROSS Device2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946416 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946423 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946430 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946447 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946454 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946461 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f
00860008946478 - TORUS Stent Graft System2023-09-08 The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions f

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