CavaClear Laser Sheath

Laser-powered Inferior Vena Cava Filter Retrieval Catheter

Spectranetics, Inc.

The following data is part of a De Novo classification by Spectranetics, Inc. with the FDA for Cavaclear Laser Sheath.

Pre-market Notification Details

DeNovo IDDEN210024
Device Name:CavaClear Laser Sheath
ClassificationLaser-powered Inferior Vena Cava Filter Retrieval Catheter
Applicant Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
ContactSondra Chandler
Product CodeQRJ  
CFR Regulation Number870.5125 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypeDirect
Date Received2021-06-25
Decision Date2021-12-21
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813132022976 DEN210024 000
00813132022969 DEN210024 000

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