FDA.reportPublic FDA data

APTUS Heli-FX®

Primary DI
00643169647572
Brand
APTUS Heli-FX®
Company
MEDTRONIC, INC.
Model
SG-64
Device description
GUIDE SG-64 AAA ENDOANCHOR 62CM MDT
Published
2015-10-21
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
K140036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140036000APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHAptus Endosystems, Inc.2014-02-06OTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169647572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169647572006431696475726431696475720643169647572

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter5.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00(10-40° C)(30-75% RH)
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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

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
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