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Heli-FX™ EndoAnchor™ System

FDA UDI

Class II (US FDA UDI)

by Medtronic Vascular, Inc.

Identity

Trade Name
Heli-FX™ EndoAnchor™ System FDA UDI
Generic Name
Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name
ACC HA-18-114 TAA APPL-CASS 10 EIFU US FDA UDI
Model / Reference
HA-18-114 FDA UDI
Description
ACC HA-18-114 TAA APPL-CASS 10 EIFU US FDA UDI

Identifiers

Primary DI / UDI-DI
00763000225940 FDA UDI
510(k) Number
K171427 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 114.0 Centimeter FDA UDI

Heli-FX™ EndoAnchor™ System by Medtronic Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K171427 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Vascular, Inc.

Sources (1)

  • FDA UDI d96630fd-f144-42a4-94dc-7e5943b3e012 38 fields · synced May 30, 2026