FDA 510(k)

MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR

K-Number: K031578 · 2003-08-01

Decision Date2003-08-01

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR is the device name listed in this FDA 510(k) record. The listed applicant is Micrus Corp.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K031578. 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 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR?

MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Micrus Corp.. The 510(k) number is K031578.

When did MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR receive FDA 510(k) clearance?

MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031578.

Who is the listed applicant for MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR?

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

What is the FDA product code for MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR?

The FDA product code for MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR is HCG.

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Other records listing Micrus Corp. as applicant

K033813MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE K032872MICRUS MICROCOIL SYSTEM K032624MICRUS MICROCATHETER K022420MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 K002056MICRUS MICROCOIL DELIVERY SYSTEM, MDS03

Related Devices (Code: HCG)

Official Source

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