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4 Fr PV Catheter

FDA UDI

Class II (US FDA UDI)

by Cd Leycom BV

Identity

Trade Name
4 Fr PV Catheter FDA UDI
Generic Name
Intracardiac catheter-tip electrode FDA UDI
Device Name
4 French PV Loop catheter with 6 mm electrode spacing FDA UDI
Model / Reference
CA-41063-PN FDA UDI
Description
4 French PV Loop catheter with 6 mm electrode spacing FDA UDI

Identifiers

Catalog Number
CDL014 FDA UDI
Primary DI / UDI-DI
08719327737309 FDA UDI
510(k) Number
K031599 FDA UDI
FDA Product Code
OBJ FDA UDI
DQO FDA UDI
GMDN Term
Intracardiac catheter-tip electrode 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intracardiac catheter-tip electrode

4 Fr PV Catheter by Cd Leycom BV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac catheter-tip electrode.

Cleared under the same submission

K031599 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cd Leycom BV

Sources (1)

  • FDA UDI 3eb3760a-98cb-4079-b182-0700cdff120a 35 fields · synced May 30, 2026