510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100454Substantially Equivalent

Hydrocoil Embolic System-Hydroframe Model 100931Hfm-V, 101243Hfm-V, 180827Hfm-V, 181139Hfm-V, 181445Hfm-V, 181850Hfm-V

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

K100454 is the FDA 510(k) clearance record for HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V, 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 no recalls naming K100454.

Clearance record

Decision date
Received
(64 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
MicroVention, Inc. 1311 Valencia Ave., Tistin 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 November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HCG, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260
November 20260