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FDA 510(k)

REVIVE INTERMEDIATE CATHETER (REVIVE IC)

K-Number: K112828 · 2011-10-25

ApplicantCodman & Shurtleff, Inc.
Decision Date2011-10-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REVIVE INTERMEDIATE CATHETER (REVIVE IC) is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2011-10-25 under 510(k) number K112828. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVIVE INTERMEDIATE CATHETER (REVIVE IC)?

REVIVE INTERMEDIATE CATHETER (REVIVE IC) is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K112828.

When did REVIVE INTERMEDIATE CATHETER (REVIVE IC) receive FDA 510(k) clearance?

REVIVE INTERMEDIATE CATHETER (REVIVE IC) received FDA 510(k) clearance on 2011-10-25, under 510(k) number K112828.

Who is the listed applicant for REVIVE INTERMEDIATE CATHETER (REVIVE IC)?

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

What is the FDA product code for REVIVE INTERMEDIATE CATHETER (REVIVE IC)?

The FDA product code for REVIVE INTERMEDIATE CATHETER (REVIVE IC) is DQY.

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Related Devices (Code: DQY)

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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.

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