510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K213200Substantially Equivalent

Solus Gold Embolization Device

Artio Medical, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213200 is the FDA 510(k) clearance record for Solus Gold Embolization Device, a class II device, cleared for Artio Medical, Inc. on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list one 510(k) clearance for Artio Medical, Inc. As of , FDA records show no recalls naming K213200.

Clearance record

Decision date
Received
(173 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Artio Medical, Inc. 127 Independence Dr., Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRD

Trailing 12 months
7 clearances under product code KRD in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20260