Cleared Traditional

K253692 - AVVIGO™+ Multi-Modality Guidance System

K253692 is an FDA 510(k) clearance for AVVIGO+ Multi-Modality Guidance System, manufactured by Boston Scientific. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K253692 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
273d
Days
Class 2
Risk

K253692 is an FDA 510(k) clearance for the AVVIGO™+ Multi-Modality Guidance System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on August 21, 2026 after a review of 273 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific devices

FDA 510(k) Submission Details - K253692

510(k) Number K253692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date August 21, 2026
Days to Decision 273 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 125d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 320
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K253692.
Affera Integrated Mapping System
K262005 · Medtronic, Inc. · Aug 2026
CorVista System® with PCWP Add-On
K253576 · Analytics For Life, Inc. · Jul 2026
EnSite™ X EP System
K262006 · Abbott Medical · Jul 2026
ScioCardio ECG Analysis Platform
K252978 · Synergen Technology Labs, LLC · Jul 2026
ILR ECG Analyzer (IM007)
K253463 · Implicity, Inc. · Jul 2026
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
K253088 · Micropace Pty, Ltd. · Jun 2026