Not Cleared Direct

DEN240017 - ShortCut (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240017 · Pi-Cardia, Ltd. · Cardiovascular device
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Sep 2024
Decision
163d
Days
Class 2
Risk

DEN240017 is an FDA 510(k) submission (not cleared) for the ShortCut. Classified as Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (product code SCZ), Class II - Special Controls.

Submitted by Pi-Cardia, Ltd. (Rehovot, IL). The FDA issued a Not Cleared (DENG) decision on September 27, 2024 after a review of 163 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1254 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

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Submission Details

510(k) Number DEN240017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 17, 2024
Decision Date September 27, 2024
Days to Decision 163 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics

Device Classification

Product Code SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1254
Definition The Device Is A Single Use Percutaneous Catheter System Intended For Mechanically Splitting Aortic Valve Leaflets That May Prevent Coronary Artery Ostia Obstruction During Planned Transcatheter Valve Procedures.
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.