QRJ · Class II · 21 CFR 870.5125

FDA Product Code QRJ: Laser-powered Inferior Vena Cava Filter Retrieval Catheter

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.

Leading manufacturers include Spectranetics, Inc..

1
Total
0
Cleared
179d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Laser-powered Inferior Vena Cava Filter Retrieval Catheter Devices (Product Code QRJ)

1 devices
1–1 of 1
Not Cleared Dec 21, 2021
CavaClear Laser Sheath
DEN210024
Spectranetics, Inc.
Cardiovascular · 179d

About Product Code QRJ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QRJ since 2021, with 0 receiving FDA clearance (average review time: 179 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QRJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →