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Foresight ICE™ Catheter

FDA UDI

Class II (US FDA UDI)

by Conavi Medical Inc

Identity

Trade Name
Foresight ICE™ Catheter FDA UDI
Generic Name
Intracardiac ultrasound imaging catheter, steerable, single-use FDA UDI
Device Name
Imaging catheter FDA UDI
Model / Reference
TA-01-0001 FDA UDI
Description
Imaging catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00628055603016 FDA UDI
510(k) Number
K162789 FDA UDI
FDA Product Code
DQO FDA UDI
ITX 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
892.1570 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

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

Foresight ICE™ Catheter by Conavi Medical 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

K162789 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conavi Medical Inc

Sources (1)

  • FDA UDI 10b42b18-3fd2-4f2d-8a00-265ed8b5adff 35 fields · synced May 30, 2026