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Lmi Occlusion Catheter

FDA UDI

Class II (US FDA UDI)

by Lucas Medical Inc

Identity

Trade Name
LMI OCCLUSION CATHETER FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Model / Reference
3FOCC40 FDA UDI

Identifiers

Primary DI / UDI-DI
B3803FOCC400 FDA UDI
510(k) Number
K955125 FDA UDI
FDA Product Code
DXE FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 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 Occlusion 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

K955125 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 9180194a-f7b4-465f-8427-7bb478277b99 33 fields · synced Jun 6, 2026