EndoForce

Primary DI
00860014060601
Brand
EndoForce
Company
Phraxis Inc.
Model
EFORCE-100
Device description
The EndoForce™ Connector for Endovascular Venous Anastomosis (herein referred to as the EndoForce™ System) includes an implantable component, the EndoForce™ Connector and a delivery system, EndoForce™ Connector Delivery System. The EndoForce Connector™ is a venous anastomosis implant used in conjunction with a 6 mm inner diameter expanded polytetrafluoroethylene (ePTFE) arteriovenous graft (not provided). The graft is sutured to the artery using a conventional anastomosis. The graft, and not the EndoForce™ Connector, is to be used for vascular access during hemodialysis in patients with end stage renal disease. The EndoForce™ Connector is provided pre-loaded within the EndoForce™ Connector Delivery System.
Published
2025-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SEQCovered Stent Vascular Connector, Hemodialysis Access Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEQCovered Stent Vascular Connector, Hemodialysis Access CircuitUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240004000EndoForce Connector for Endovascular Venous AnastomosisPhraxis, Inc.2025-05-15SEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014060601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014060601008600140606018600140606010860014060601

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftAn implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Length66Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8043574772gbeecher@phraxis.com

Regulatory Flags#

DUNS number
825429017
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true