FDA.reportPublic FDA data

Heli-FX™ EndoAnchor™ System

Primary DI
00763000225971
Brand
Heli-FX™ EndoAnchor™ System
Company
MEDTRONIC, INC.
Model
HG-16-62-28
Device description
GUIDE HG-16-62-28 AAA ENDOANCH 28 EIFU
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K171427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171427000Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.2017-06-13OTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000225971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000225971007630002259717630002259710763000225971

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
Length28Millimeter
Length62Centimeter
Outer Diameter5.3Millimeter

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
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000645113Heli-FX™ EndoAnchor™ SystemMEDTRONIC, INC.OTD2022-10-22
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
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