Cleared Traditional

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM (K070051) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070051 · Acumen Medical, Inc. · Cardiovascular device
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Apr 2007
Decision
92d
Days
Class 2
Risk

K070051 is an FDA 510(k) clearance for the ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Acumen Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 6, 2007 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Acumen Medical, Inc. devices

Submission Details

510(k) Number K070051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2007
Decision Date April 06, 2007
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 888
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