510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223386Substantially Equivalent

Optima Coil System

Balt USA, LLC, Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223386 is the FDA 510(k) clearance record for Optima Coil System, a class II device, cleared for Balt USA, LLC on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 19 510(k) clearances for Balt USA, LLC, from to . As of , FDA records show one recall naming K223386.

Clearance record

Decision date
Received
(29 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Balt USA, LLC 29 Parker, Irvine 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