510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050954Substantially Equivalent

Microplex Coil System (Mcs) and Hydrocoil Embolic System (Hes)

Terumo Cardiovascular Systems Corporation, Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050954 is the FDA 510(k) clearance record for MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES), a class II device, cleared for MicroVention, Inc. on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 160 510(k) clearances for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, from to . As of , FDA records show 16 recalls naming K050954.

Clearance record

Decision date
Received
(74 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
MicroVention, Inc. 75 Columbia, Aliso Viejo 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