510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230064Unknown

BraidE Embolization Assist Device

Rapid Medical Inc., Yokneam, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230064 is the FDA 510(k) clearance record for BraidE Embolization Assist Device, a class II device, cleared for Rapid Medical Ltd. on under FDA product code QZU (Temporary Embolization Assist Device, Peripheral). FDA's definition for product code QZU reads: "A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature...". FDA records list 10 510(k) clearances for Rapid Medical Ltd., from to . As of , FDA records show no recalls naming DEN230064.

Clearance record

Decision date
Received
(155 days to decision)
Product code
QZU Temporary Embolization Assist Device, Peripheral
Regulation
21 CFR 870.3325
Device class
Class II
Review panel
Cardiovascular
Applicant
Rapid Medical Ltd. Carmel Bldg., Pob 337, Yokneam, IL
Third party review
No

Clearances, product code QZU

Trailing 12 months

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

FDA records show no clearances under product code QZU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZU, 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