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FDA 510(k)

LASSO NAV DUO LOOP CATHETER

K-Number: K130602 · 2013-08-14

ApplicantBiosense Webster, Inc.
Decision Date2013-08-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LASSO NAV DUO LOOP 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 2013-08-14 under 510(k) number K130602. 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 LASSO NAV DUO LOOP CATHETER?

LASSO NAV DUO LOOP CATHETER is a medical device that received FDA 510(k) clearance on 2013-08-14. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K130602.

When did LASSO NAV DUO LOOP CATHETER receive FDA 510(k) clearance?

LASSO NAV DUO LOOP CATHETER received FDA 510(k) clearance on 2013-08-14, under 510(k) number K130602.

Who is the listed applicant for LASSO NAV DUO LOOP 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 LASSO NAV DUO LOOP CATHETER?

The FDA product code for LASSO NAV DUO LOOP 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.

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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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