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FDA 510(k)

HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS

K-Number: K080666 · 2008-07-11

ApplicantMicroVention, Inc.
Decision Date2008-07-11
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K080666. 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 HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS?

HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is MicroVention, Inc.. The 510(k) number is K080666.

When did HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS receive FDA 510(k) clearance?

HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS received FDA 510(k) clearance on 2008-07-11, under 510(k) number K080666.

Who is the listed applicant for HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS?

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 HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS?

The FDA product code for HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS is HCG.

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Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

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.

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