FDA 510(k)

DELTAMAXX 18 MICROCOIL SYSTEM

K-Number: K120274 · 2012-03-02

Decision Date2012-03-02

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DELTAMAXX 18 MICROCOIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Codman and Shurtleff, Inc.. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K120274. 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 DELTAMAXX 18 MICROCOIL SYSTEM?

DELTAMAXX 18 MICROCOIL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Codman and Shurtleff, Inc.. The 510(k) number is K120274.

When did DELTAMAXX 18 MICROCOIL SYSTEM receive FDA 510(k) clearance?

DELTAMAXX 18 MICROCOIL SYSTEM received FDA 510(k) clearance on 2012-03-02, under 510(k) number K120274.

Who is the listed applicant for DELTAMAXX 18 MICROCOIL SYSTEM?

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

What is the FDA product code for DELTAMAXX 18 MICROCOIL SYSTEM?

The FDA product code for DELTAMAXX 18 MICROCOIL SYSTEM is HCG.

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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.