510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172390Substantially Equivalent

Optima Coil System

Blockade Medical, LLC (D.B.A. Balt USA), Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172390 is the FDA 510(k) clearance record for Optima Coil System, a class II device, cleared for Blockade Medical, LLC (D.B.A. Balt Usa) on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list one 510(k) clearance for Blockade Medical, LLC (D.B.A. Balt Usa). As of , FDA records show 4 recalls naming K172390.

Clearance record

Decision date
Received
(194 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Blockade Medical, LLC (D.B.A. Balt Usa) 18 Technology Dr. Suite 169, 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