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FDA 510(k)

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

K-Number: K053194 · 2006-03-09

ApplicantBiosense Webster, Inc.
Decision Date2006-03-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE 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 2006-03-09 under 510(k) number K053194. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE?

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K053194.

When did NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE receive FDA 510(k) clearance?

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE received FDA 510(k) clearance on 2006-03-09, under 510(k) number K053194.

Who is the listed applicant for NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE?

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 NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE?

The FDA product code for NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE is DQK.

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Other records listing Biosense Webster, Inc. as applicant

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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