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FDA 510(k)

AVVIGO™+ Multi-Modality Guidance System

K-Number: K253692 · 2026-08-21

ApplicantBoston Scientific
Decision Date2026-08-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVVIGO™+ Multi-Modality Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K253692. 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 AVVIGO™+ Multi-Modality Guidance System?

AVVIGO™+ Multi-Modality Guidance System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Boston Scientific. The 510(k) number is K253692.

When did AVVIGO™+ Multi-Modality Guidance System receive FDA 510(k) clearance?

AVVIGO™+ Multi-Modality Guidance System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253692.

Who is the listed applicant for AVVIGO™+ Multi-Modality Guidance System?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVVIGO™+ Multi-Modality Guidance System?

The FDA product code for AVVIGO™+ Multi-Modality Guidance System is DQK.

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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.

K262005Affera Integrated Mapping SystemMedtronic, Inc.K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, 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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