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CardioInsight™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
CardioInsight™ FDA UDI
Generic Name
Cardiac mapping system FDA UDI
Device Name
MAPPING SYSTEM CIT200 CIT US FDA UDI
Model / Reference
CIT200 FDA UDI
Description
MAPPING SYSTEM CIT200 CIT US FDA UDI

Identifiers

Primary DI / UDI-DI
00643169723603 FDA UDI
510(k) Number
K162440 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac mapping system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac mapping system

CardioInsight™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system.

Cleared under the same submission

K162440 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 0ba69145-5462-4677-9bbd-19d5cad87b2f 36 fields · synced May 30, 2026