510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QRJClass II

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

21 CFR 870.5125 / Cardiovascular
FDA source (opens on fda.gov)

QRJ is the FDA product code for Laser-Powered Inferior Vena Cava Filter Retrieval Catheter, a class II device type, regulated under 21 CFR 870.5125. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QRJ
Device name
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
FDA 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.
Regulation
21 CFR 870.5125
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QRJ

By decision year
1 clearance under product code QRJ with a decision year between 2021 and 2021, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QRJ by decision year
YearClearances
20211

Applicants with the most clearances

Product code QRJ
Applicants holding the most 510(k) clearances under product code QRJ
ApplicantClearances
Spectranetics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code