Not Cleared Direct

DEN210024 - CavaClear Laser Sheath (FDA 510(k) Clearance)

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

DEN210024 · Spectranetics, Inc. · Cardiovascular device
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Dec 2021
Decision
179d
Days
Class 2
Risk

DEN210024 is an FDA 510(k) submission (not cleared) for the CavaClear Laser Sheath. Classified as Laser-powered Inferior Vena Cava Filter Retrieval Catheter (product code QRJ), Class II - Special Controls.

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2021 after a review of 179 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5125 - 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.

View all Spectranetics, Inc. devices

Submission Details

510(k) Number DEN210024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 25, 2021
Decision Date December 21, 2021
Days to Decision 179 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics

Device Classification

Product Code QRJ Laser-powered Inferior Vena Cava Filter Retrieval Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5125
Definition A Laser-powered Inferior Vena Cava (ivc) Filter Retrieval Catheter Is A Percutaneous Catheter That Uses A Laser To Ablate Tissue And Is Intended To Facilitate In The Detachment And Removal Of Indwelling Ivc Filters.
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.