510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K073419Substantially Equivalent

Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization Particles

Rj Medical, Inc., El Dorado Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073419 is the FDA 510(k) clearance record for PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES, a class II device, cleared for Rj Medical, Inc. on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 2 510(k) clearances for Rj Medical, Inc., from to . As of , FDA records show no recalls naming K073419.

Clearance record

Decision date
Received
(71 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Rj Medical, Inc. 4921 Robert J. Mathews Pkwy., El Dorado Hills CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCG

Trailing 12 months
5 clearances under product code HCG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HCG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260