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FDA 510(k)

CERENOVUS Large Bore Catheter

K-Number: K191237 · 2019-11-08

ApplicantCodman & Shurtleff, Inc.
Decision Date2019-11-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CERENOVUS Large Bore Catheter is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval number K191237. 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 CERENOVUS Large Bore Catheter?

CERENOVUS Large Bore Catheter is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K191237.

When was CERENOVUS Large Bore Catheter approved by the FDA?

CERENOVUS Large Bore Catheter received FDA 510(k) clearance on 2019-11-08, under approval number K191237.

What company makes CERENOVUS Large Bore Catheter?

CERENOVUS Large Bore Catheter is manufactured by Codman & Shurtleff, Inc..

What is the FDA product code for CERENOVUS Large Bore Catheter?

The FDA product code for CERENOVUS Large Bore Catheter is 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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