FDA 510(k)

HydroCoil Embolic System (HES)

K-Number: K161367 · 2016-08-31

Decision Date2016-08-31

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

HydroCoil Embolic System (HES) is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K161367. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroCoil Embolic System (HES)?

HydroCoil Embolic System (HES) is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is MicroVention, Inc.. The 510(k) number is K161367.

When did HydroCoil Embolic System (HES) receive FDA 510(k) clearance?

HydroCoil Embolic System (HES) received FDA 510(k) clearance on 2016-08-31, under 510(k) number K161367.

Who is the listed applicant for HydroCoil Embolic System (HES)?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HydroCoil Embolic System (HES)?

The FDA product code for HydroCoil Embolic System (HES) is HCG.

Other records listing MicroVention, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210030Stent, carotid PMA P170032Intrasaccular Flow Disruption Device PMA P180027Intracranial aneurysm flow diverter K243638MV Flow Aspiration Pump (MVFLOWPMP01)PMA P170013Intracranial coil-assist stent K232542Wedge XL Delivery Catheter

View all 29 devices →

Related Devices (Code: HCG)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.