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FDA 510(k)

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER

K-Number: K031161 · 2003-07-22

ApplicantBiosense Webster, Inc.
Decision Date2003-07-22
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2003-07-22 under 510(k) number K031161. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER?

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER is a medical device that received FDA 510(k) clearance on 2003-07-22. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K031161.

When did VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER receive FDA 510(k) clearance?

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER received FDA 510(k) clearance on 2003-07-22, under 510(k) number K031161.

Who is the listed applicant for VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER?

The FDA product code for VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER is DRF.

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Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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