APTUS Heli-FX®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: APTUS Heli-FX® FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: GUIDE SG-64 AAA ENDOANCHOR 62CM MDT FDA UDI
Model / Reference: SG-64 FDA UDI
Description: GUIDE SG-64 AAA ENDOANCHOR 62CM MDT FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169647572 FDA UDI
510(k) Number: K140036 FDA UDI
FDA Product Code: OTD FDA UDI
GMDN Term: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.3 Millimeter FDA UDI

Category: Soft-tissue/mesh anchor, non-bioabsorbable

APTUS Heli-FX® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Soft-tissue/mesh anchor, non-bioabsorbable.

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MectaLock PEEK Suture Anchor — Medacta International · Class II
MectaScrew PEEK — Medacta International · Class II
Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II

Cleared under the same submission

K140036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI 19fb9b0a-d593-47ab-9057-09bbc1f02f3f 37 fields · synced Jun 1, 2026