← Back to catalogue

Lmi Occlusion Catheter

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K955125

by Lucas Medical Inc

Identity

Trade Name
LMI OCCLUSION CATHETER FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Model / Reference
3FOCC23 FDA UDI

Identifiers

Primary DI / UDI-DI
B3803FOCC230 FDA UDI
510(k) Number
K955125 FDA 510(k)FDA UDI
FDA Product Code
DXE FDA 510(k)FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.5150 FDA 510(k)
Regulation Number
870.5150 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Lmi Occlusion Catheter by Lucas Medical Inc — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lucas Medical Inc
FDA Applicant
Lucas Medical, Inc.

Sources (2)

  • FDA 510(k) K955125 24 fields · synced Jun 18, 2026
  • FDA UDI 28653608-d4f4-43aa-97ef-b43d8b49dcdb 33 fields · synced May 26, 2026