Flexcel Carotid Shunt

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name: Flexcel Carotid Shunt FDA UDI
Generic Name: Carotid artery shunt FDA UDI
Device Name: Flexcel Carotid Shunt (12F) FDA UDI
Model / Reference: 2020-35 FDA UDI
Description: Flexcel Carotid Shunt (12F) FDA UDI

Identifiers

Catalog Number: 2020-35 FDA UDI
Primary DI / UDI-DI: 00840663101405 FDA UDI
510(k) Number: K071367 FDA UDI
FDA Product Code: MJN FDA UDI
GMDN Term: Carotid artery shunt FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

FDA UDI

Category: Carotid artery shunt

Flexcel Carotid Shunt by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carotid artery shunt.

LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
Sundt™ — Integra Lifesciences Corp. · Class II
LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
CAROTID ENDARTERECTOMY SHUNT — LUCAS MEDICAL INC · Class II
LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER — LUCAS MEDICAL INC · Class II
CAROTID ENDARTERECTOMY SHUNT — LUCAS MEDICAL INC · Class II
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER — LUCAS MEDICAL INC · Class II

Cleared under the same submission

K071367 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: LeMaitre Vascular, Inc.

Sources (1)

FDA UDI a57194cf-0248-4f75-ad86-5ff51746feba 36 fields · synced Jun 9, 2026