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Lasso

FDA UDI

Class II (US FDA UDI)

by Biosense Webster Inc

Identity

Trade Name
Lasso FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, single-use FDA UDI
Model / Reference
D7L102515RT FDA UDI

Identifiers

Catalog Number
D7L102515RT FDA UDI
Primary DI / UDI-DI
10846835000306 FDA UDI
510(k) Number
K031161 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

Category: Cardiac mapping catheter, percutaneous, single-use

Lasso 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

K031161 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 59e4c7d5-baeb-47e3-bb20-0288b3f0f316 36 fields · synced May 30, 2026