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Product codes
QRJ
Product code QRJ
Device name
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.5125
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
DEN210024
CavaClear Laser Sheath
Spectranetics, Inc.
2021-12-21
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
00813132022969
CavaClear laser sheath
Philips Image Guided Therapy Corporation
2022-03-03
00813132022976
CavaClear laser sheath
Philips Image Guided Therapy Corporation
2022-03-03