FDA.reportPublic FDA data

ENDOCROSS Device

Primary DI
00850032145008
Brand
ENDOCROSS Device
Company
Endologix LLC
Model
ENDOCROSS
Catalog number
ENDOCROSS
Device description
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
Published
2025-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWMStent Graft, Bypass, Superficial Femoral Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWMStent Graft, Bypass, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220021005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220021005DETOUR SystemEndologix, LLC2023-06-07QWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032145008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032145008008500321450088500321450080850032145008

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
(949) 595-7200CustomerService@endologix.com

Regulatory Flags#

DUNS number
179593652
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007370152Ovation iX Iliac Stent GraftTV-IL141280-JTV-IL141280-J2023-03-03
00850007370169Ovation iX Iliac Stent GraftTV-IL1412100-JTV-IL1412100-J2023-03-03
00850007370176Ovation iX Iliac Stent GraftTV-IL1412120-JTV-IL1412120-J2023-03-03
00850007370183Ovation iX Iliac Stent GraftTV-IL1412140-JTV-IL1412140-J2023-03-03
00850007370213Ovation iX Iliac Stent GraftTV-IL1414120-JTV-IL1414120-J2023-03-03
00850007370411Ovation iX Iliac Stent GraftTV-IL1412160-JTV-IL1412160-J2023-03-03
00850007370428Ovation iX Iliac Stent GraftTV-IL1414100-JTV-IL1414100-J2023-03-03
00850007370091Ovation iX Iliac Stent GraftTV-IL1428140-JTV-IL1428140-J2023-03-02
00850007370107Ovation iX Iliac Stent GraftTV-IL141480-JTV-IL141480-J2023-03-02
00850007370114Ovation iX Iliac Stent GraftTV-IL1410160-JTV-IL1410160-J2023-03-02
00850007370190Ovation iX Iliac Stent GraftTV-IL1428120-JTV-IL1428120-J2023-03-02
00850007370206Ovation iX Iliac Stent GraftTV-IL1428100-JTV-IL1428100-J2023-03-02
00850007370220Ovation iX Iliac Stent GraftTV-IL1414140-JTV-IL1414140-J2023-03-02
00850007370237Ovation iX Iliac Stent GraftTV-IL141680-JTV-IL141680-J2023-03-02
00850007370244Ovation iX Iliac Stent GraftTV-IL1416100-JTV-IL1416100-J2023-03-02
00850007370251Ovation iX Iliac Stent GraftTV-IL1416120-JTV-IL1416120-J2023-03-02
00850007370268Ovation iX Iliac Stent GraftTV-IL1416140-JTV-IL1416140-J2023-03-02
00850007370275Ovation iX Iliac Stent GraftTV-IL141880-JTV-IL141880-J2023-03-02
00850007370282Ovation iX Iliac Stent GraftTV-IL1418100-JTV-IL1418100-J2023-03-02
00850007370299Ovation iX Iliac Stent GraftTV-IL1418120-JTV-IL1418120-J2023-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850032145015TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145022TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145039TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145046TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145053TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145060TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145077TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00860008946409ENDOCROSS DevicePQ Bypass, Inc.QWM2023-08-31
00860008946416TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946423TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946430TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946447TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946454TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946461TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946478TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31