Identity
- Trade Name
- Tack Endovascular System (6F, 4.0-8.0mm) FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Device Name
- 80cm Catheter Length FDA UDI
- Model / Reference
- 206080061 FDA UDI
- Description
- 80cm Catheter Length FDA UDI
Identifiers
- Catalog Number
- 206080061 FDA UDI
- Primary DI / UDI-DI
- 00850003494050 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
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 80 Centimeter FDA UDI
Category: Peripheral artery stent, bare-metal
Tack Endovascular System (6F, 4.0-8.0mm) by Intact Vascular, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Intact Vascular, Inc.
Sources (2)
- FDA UDI 3883d2b6-12ce-4016-93a6-d6cbe6d86c70 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026