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FDA 510(k)

LASSO NAV CATHETER

K-Number: K093376 · 2010-06-18

ApplicantBiosense Webster, Inc.
Decision Date2010-06-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LASSO NAV 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 2010-06-18 under 510(k) number K093376. 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 CATHETER?

LASSO NAV CATHETER is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K093376.

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

LASSO NAV CATHETER received FDA 510(k) clearance on 2010-06-18, under 510(k) number K093376.

Who is the listed applicant for LASSO NAV 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 CATHETER?

The FDA product code for LASSO NAV CATHETER is DRF.

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Other records listing Biosense Webster, Inc. as applicant

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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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