FDA.reportPublic FDA data

Heli-FX™ EndoAnchor™ System

Primary DI
00763000645113
Brand
Heli-FX™ EndoAnchor™ System
Company
MEDTRONIC, INC.
Model
SA-85
Device description
ACC SA-85 AAA APPL-CASSETTE 10 EIFU US
Published
2022-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTDEndovascular suturing system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTDEndovascular Suturing SystemCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182957000Heli-FX EndoAnchor SystemMedtronic Vascular, Inc.2018-11-21OTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000645113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000645113007630006451137630006451130763000645113

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length86Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™W4TR012017-10-20
00643169891425Serena™ CRT-P MRI SureScan™W1TR022017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™W4TR022017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000645120Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2022-10-22
00763000645137Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000645144Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000645151Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000645168Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000645175Heli-FX™ Thoracic EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000645182Heli-FX™ Ancillary EndoAnchor™ CassetteMEDTRONIC VASCULAR, INC.OTD2022-10-22
00763000225957Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-09-16
00763000225933Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-06-29
00763000225940Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2019-06-29
00763000225988Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-06-29
00763000225995Heli-FX™ EndoAnchor™ SystemMEDTRONIC VASCULAR, INC.OTD2019-06-29
00763000226008Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-06-29
00763000225964Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-05-10
00763000225971Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2019-05-10
00763000025250Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-11-10
00763000025267Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-11-10
00763000025274Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-11-10
00763000025281Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-11-10
00763000025298Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-11-10
00763000006624Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-09-17
00763000006631Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-09-17
00763000006655Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-09-17
00763000006662Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-09-17
00763000006679Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-09-17
00763000006617Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-08-06
00763000006648Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-08-06
00763000006686Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2017-08-06
00643169647565APTUS Heli-FX®MEDTRONIC VASCULAR, INC.OTD2015-10-21
00643169647572APTUS Heli-FX®MEDTRONIC, INC.OTD2015-10-21