510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210024Unknown

CavaClear Laser Sheath

Spectranetics Corp., Colorado Springs CO / Direct, Unknown
FDA source (opens on fda.gov)

DEN210024 is the FDA 510(k) clearance record for CavaClear Laser Sheath, a class II device, cleared for Spectranetics, Inc. on under FDA product code QRJ (Laser-Powered Inferior Vena Cava Filter Retrieval Catheter). FDA's definition for product code QRJ 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". FDA records list 57 510(k) clearances for Spectranetics, Inc., from to . As of , FDA records show no recalls naming DEN210024.

Clearance record

Decision date
Received
(179 days to decision)
Product code
QRJ Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
Regulation
21 CFR 870.5125
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectranetics, Inc. 9965 Federal Dr., Colorado Springs CO
Third party review
No

Clearances, product code QRJ

Trailing 12 months

FDA records hold no clearances under product code QRJ in the trailing twelve months.

FDA records show no clearances under product code QRJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QRJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260