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Lmi Bilumen Irrigation (proximal) Arterial Embolectomy Catheter

FDA UDI

Class II (US FDA UDI)

by Lucas Medical Inc

Identity

Trade Name
LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLECTOMY CATHETER FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Model / Reference
4FIRR040P FDA UDI

Identifiers

Primary DI / UDI-DI
B3804FIRR040P0 FDA UDI
510(k) Number
K955499 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided 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

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

Lmi Bilumen Irrigation (proximal) Arterial Embolectomy Catheter by Lucas Medical 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

K955499 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lucas Medical Inc

Sources (1)

  • FDA UDI 542363e4-fea4-442d-8c45-68aeac8d5815 33 fields · synced Jun 1, 2026