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Polyurethane Dual Lumen Occlusion Catheter

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name
Polyurethane Dual Lumen Occlusion Catheter FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
Polyurethane Dual Lumen Occlusion Catheter, 4F, 80cm FDA UDI
Model / Reference
4F-2L-80 FDA UDI
Description
Polyurethane Dual Lumen Occlusion Catheter, 4F, 80cm FDA UDI

Identifiers

Catalog Number
4F-2L-80 FDA UDI
Primary DI / UDI-DI
00840663102266 FDA UDI
510(k) Number
K844918 FDA UDI
FDA Product Code
DQT FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

Polyurethane Dual Lumen Occlusion Catheter by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Cleared under the same submission

K844918 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA UDI 910f841f-f1f4-4ac7-8f97-02d9f68f7baa 36 fields · synced Jun 9, 2026