DeviceClearance

Product code QRJ— Cardiovascular

CavaClear Laser Sheath

Classification name
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
Device class
Class 2
Regulation
21 CFR 870.5125
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QRJ under 21 CFR 870.5125, via openFDA

Market context for product code QRJ

FDA has cleared 1 device under product code QRJ, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QRJ

Recent clearances under product code QRJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.