Tack Endovascular System (6F, 4.0-8.0mm)

FDA UDI

Class III (US FDA UDI)

by Intact Vascular, Inc.

Identity

Trade Name: Tack Endovascular System (6F, 4.0-8.0mm) FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Device Name: 120cm Catheter Length FDA UDI
Model / Reference: 206120061 FDA UDI
Description: 120cm Catheter Length FDA UDI

Identifiers

Catalog Number: 206120061 FDA UDI
Primary DI / UDI-DI: 00850003494043 FDA UDI
FDA Product Code: QCT FDA UDI
GMDN Term: Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class: Class III 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Length — 120 Centimeter FDA UDI

Category: Peripheral artery stent, bare-metal

Tack Endovascular System (6F, 4.0-8.0mm) by Intact Vascular, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery stent, bare-metal.

Innova™ Vascular — Boston Scientific · Class III
Pulsar-18 — Biotronik, Inc. · Class III
LifeStent® Solo Vascular Stent — Bard Peripheral Vascular · Class III
Astron — Biotronik, Inc. · Class III
Absolute Pro — Abbott Vascular · Class III
Protégé™ GPS™ — EV3, INC · Class II
COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
Zilver 518 — Cook Ireland, Ltd. · Class III

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 III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Intact Vascular, Inc.

Sources (1)

FDA UDI a4aad605-d300-445b-be1f-188f351148eb 37 fields · synced Jun 6, 2026