510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042297Substantially Equivalent

Ultra Ivalon and Ultra Drivalon Pva Embolization Particles

Acta Vascular Systems, Inc., Los Gatos CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042297 is the FDA 510(k) clearance record for ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES, a class II device, cleared for Acta Vascular Systems, Inc. on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list one 510(k) clearance for Acta Vascular Systems, Inc. As of , FDA records show no recalls naming K042297.

Clearance record

Decision date
Received
(281 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Acta Vascular Systems, Inc. 247 Marchmont Dr., Los Gatos 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