FDA.reportPublic FDA data

APTUS Heli-FX®

Primary DI
00643169647565
Brand
APTUS Heli-FX®
Company
MEDTRONIC VASCULAR, INC.
Model
HG-18-90-42
Device description
GUIDE HG-18-90-42 TAA ENDOANCH 90CM 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
00643169647565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169647565006431696475656431696475650643169647565

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 Diameter6Millimeter

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
080009661
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000225995Heli-FX™ EndoAnchor™ SystemHG-18-90-322019-06-29
00643169647664APTUS Heli-FX®HG-18-90-322015-10-21
00763000225940Heli-FX™ EndoAnchor™ SystemHA-18-1142019-06-29
00643169647626APTUS Heli-FX®HG-16-62-282015-10-21
00763000645137Heli-FX™ EndoAnchor™ SystemHG-16-62-282022-10-22
00763000645144Heli-FX™ Thoracic EndoAnchor™ SystemHA-18-1142022-10-22
00763000645151Heli-FX™ Thoracic EndoAnchor™ SystemHG-18-90-222022-10-22
00763000645168Heli-FX™ Thoracic EndoAnchor™ SystemHG-18-90-322022-10-22
00763000645175Heli-FX™ Thoracic EndoAnchor™ SystemHG-18-90-422022-10-22
00763000645182Heli-FX™ Ancillary EndoAnchor™ CassetteEC-052022-10-22
00643169647602APTUS Heli-FX®HA-18-1142015-10-21
00643169647640APTUS Heli-FX®HG-18-90-222015-10-21

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
00643169647572APTUS Heli-FX®MEDTRONIC, INC.OTD2015-10-21