FDA 510(k)

MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL

K-Number: K083646 · 2009-01-02

ApplicantMicrus Endovascular Corporation

Decision Date2009-01-02

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL is the device name listed in this FDA 510(k) record. The listed applicant is Micrus Endovascular Corporation. It received FDA 510(k) clearance on 2009-01-02 under 510(k) number K083646. 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 MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL?

MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL is a medical device that received FDA 510(k) clearance on 2009-01-02. The listed applicant is Micrus Endovascular Corporation. The 510(k) number is K083646.

When did MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL receive FDA 510(k) clearance?

MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL received FDA 510(k) clearance on 2009-01-02, under 510(k) number K083646.

Who is the listed applicant for MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL?

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

What is the FDA product code for MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL?

The FDA product code for MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL is HCG.

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Other records listing Micrus Endovascular Corporation as applicant

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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.