FDA.reportPublic FDA data

Heli-FX™ EndoAnchor™ System

Primary DI
00763000006679
Brand
Heli-FX™ EndoAnchor™ System
Company
MEDTRONIC, INC.
Model
HG-18-90-42
Device description
TAA GUIDE DEVICE 42 EIFU
Published
2017-09-17
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
K182957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171427000Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.2017-06-13OTD
K182957000Heli-FX EndoAnchor SystemMedtronic Vascular, Inc.2018-11-21OTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000006679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000006679007630000066797630000066790763000006679

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
Length42Millimeter
Length90Centimeter
Outer Diameter6Millimeter

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
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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
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
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