LassoStar Circular Mapping Catheter
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LASSOSTAR Circular Mapping Catheter EUDAMEDLASSOSTAR Non-NAV -Circular navigation catheter FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Device Name
- 2.44FR LASSOSTAR non-NAV,10P,15MM FDA UDI2.44FR LASSOSTAR non-NAV,10P,25MM FDA UDI2.44FR LASSOSTAR non-NAV,10P,20MM FDA UDI
- Model / Reference
- D139001 EUDAMEDFDA UDID139003 EUDAMEDFDA UDID139002 EUDAMEDFDA UDI
- Description
- 2.44FR LASSOSTAR non-NAV,10P,15MM FDA UDI2.44FR LASSOSTAR non-NAV,10P,25MM FDA UDI2.44FR LASSOSTAR non-NAV,10P,20MM FDA UDI
Identifiers
- Catalog Number
- D139001 FDA UDID139003 FDA UDID139002 FDA UDI
- Primary DI / UDI-DI
- D-USMF000014219000024QJ EUDAMEDD-USMF000014219000026QN EUDAMEDD-USMF000014219000025QL EUDAMED10846835020236 FDA UDI10846835020243 FDA UDI10846835020229 FDA UDI
- Basic UDI-DI
- B-USMF000014219000024QJ EUDAMEDB-USMF000014219000026QN EUDAMEDB-USMF000014219000025QL EUDAMED
- 510(k) Number
- FDA Product Code
- DRF FDA 510(k)FDA UDI
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The LassoStar Circular Mapping Catheter is a Catheter, Electrode Recording designed for electroanatomic mapping in cardiovascular procedures. It features a circular electrode array to acquire high-resolution electrograms, enabling detailed mapping of cardiac electrical activity for diagnostic and therapeutic interventions.
This device is intended for use in electrophysiology laboratories with compatible mapping systems, such as the CARTO 3 System. Supplied as a single-use, non-sterile product, it requires sterile preparation prior to use. The catheter is classified as Class II under FDA regulations and complies with the Medical Device Directive (MDD). Multiple model variants are available, as indicated by the registration numbers, ensuring compatibility with various procedural needs.
Frequently asked questions
What is the LassoStar Circular Mapping Catheter primarily used for in clinical settings?
The LassoStar Circular Mapping Catheter is designed for electroanatomic mapping in cardiovascular procedures. It uses a circular electrode array to acquire high-resolution electrograms, allowing clinicians to map cardiac electrical activity in detail. This aids in diagnosing and guiding therapeutic interventions, such as ablation, for arrhythmias like atrial fibrillation.
Is the LassoStar Circular Mapping Catheter sterile as shipped, and what preparation is required before use?
The LassoStar Circular Mapping Catheter is supplied as a single-use, non-sterile product. It must be sterilized prior to use in an electrophysiology laboratory, following standard sterile preparation protocols to ensure safety and compliance with clinical standards.
Are there multiple sizes or models available for the LassoStar Circular Mapping Catheter, and how do I determine compatibility?
Yes, the LassoStar Circular Mapping Catheter comes in multiple model variants, as indicated by the listed registration numbers (e.g., 3008497357, 1018233, etc.). Compatibility depends on the specific procedural needs and the CARTO 3 System or other compatible mapping systems in use. The manufacturer’s documentation or support team can confirm which model aligns with your clinical setup.
How is the LassoStar Circular Mapping Catheter regulated, and what does that mean for purchasing or use?
The LassoStar Circular Mapping Catheter is classified as Class II under FDA regulations and complies with the Medical Device Directive (MDD). It was cleared via a 510(k) pathway (Traditional Review, Substantially Equivalent determination) by the FDA’s Cardiovascular (CV) Advisory Committee. This means it meets established safety and effectiveness standards for electroanatomic mapping catheters, but purchasers should verify current regulatory status and compliance requirements with the manufacturer or local health authorities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LASSO™ Circular Mapping Catheter | J&J MedTech US, Biosense Webster LASSO Instructions For Use Manual, LASSO® Circular Mapping Catheter | Biosense Webster, PDF CIRCLE INTO HIGH-REsOLuTION ELECTROGRAMs. - Biosense Webster
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193632 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (7)
- FDA 510(k) K193632 24 fields · synced Sep 18, 2026
- FDA UDI 272a9e07-d350-4612-91c7-4c085c86dc72 38 fields · synced May 24, 2026
- FDA UDI cd747234-8263-4d55-9e60-3ab32751c36c 38 fields · synced May 30, 2026
- FDA UDI c3f9dfba-ce74-49c6-bbc1-47b2fc16704b 38 fields · synced May 30, 2026
- EUDAMED 614db08d-a31b-4137-bfe8-1c6465535de1 61 fields · synced Jul 9, 2026
- EUDAMED 6a41a037-e338-45d4-bb7e-487357f38be1 61 fields · synced Jul 27, 2026
- EUDAMED a0b02772-c948-4c3b-8292-a21505fd100e 61 fields · synced Jul 30, 2026