Visi-Pro™

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Visi-Pro™ FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Device Name: PXB35-05-27-080 STENT VISI PRO 035 V01 FDA UDI
Model / Reference: PXB35-05-27-080 FDA UDI
Description: PXB35-05-27-080 STENT VISI PRO 035 V01 FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169787599 FDA UDI
PMA Number: P030045 FDA UDI
FDA Product Code: FGE FDA UDI
NIO FDA UDI
GMDN Term: Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 27.0 Millimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Peripheral artery stent, bare-metal

Visi-Pro™ by Covidien LP — Class II — 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

Cleared under the same submission

P030045 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: Covidien LP

Sources (1)

FDA UDI d0e70531-fd03-43c8-bdb1-98263685e954 37 fields · synced Jun 8, 2026