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7FR CS Duo-Decapolar Catheter

FDA UDI

Class II (US FDA UDI)

by Biosense Webster Inc

Identity

Trade Name
7FR CS Duo-Decapolar Catheter FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, single-use FDA UDI
Model / Reference
D139801 FDA UDI

Identifiers

Catalog Number
D139801 FDA UDI
Primary DI / UDI-DI
10846835017175 FDA UDI
510(k) Number
K101991 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Cardiac mapping catheter, percutaneous, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1220 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Cardiac mapping catheter, percutaneous, single-use

7FR CS Duo-Decapolar Catheter by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping catheter, percutaneous, single-use.

Cleared under the same submission

K101991 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biosense Webster Inc

Sources (1)

  • FDA UDI 5b934f3a-0865-4357-81f2-e9eaece33615 36 fields · synced Jun 8, 2026