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AcuNav Lumos 4D ICE catheter

FDA UDI

Class II (US FDA UDI)

by Siemens Medical Solutions Usa, Inc.

Identity

Trade Name
AcuNav Lumos 4D ICE catheter FDA UDI
Generic Name
Intracardiac ultrasound imaging catheter, steerable, single-use FDA UDI
Model / Reference
11658641 FDA UDI

Identifiers

Primary DI / UDI-DI
04056869997445 FDA UDI
510(k) Number
K212959 FDA UDI
FDA Product Code
OBJ FDA UDI
GMDN Term
Intracardiac ultrasound imaging catheter, steerable, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 12.5 French FDA UDI

Category: Intracardiac ultrasound imaging catheter, steerable, single-use

AcuNav Lumos 4D ICE catheter by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac ultrasound imaging catheter, steerable, single-use.

Cleared under the same submission

K212959 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Medical Solutions Usa, Inc.

Sources (1)

  • FDA UDI c5f2172c-f3ea-46e2-a9b8-e696cf9a9e1b 36 fields · synced Jun 8, 2026