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FDA 510(k)

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

K-Number: K113845 · 2012-01-25

ApplicantMedtronic, Inc.
Decision Date2012-01-25
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2012-01-25 under 510(k) number K113845. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE?

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE is a medical device that received FDA 510(k) clearance on 2012-01-25. The listed applicant is Medtronic, Inc.. The 510(k) number is K113845.

When did TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE receive FDA 510(k) clearance?

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE received FDA 510(k) clearance on 2012-01-25, under 510(k) number K113845.

Who is the listed applicant for TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE?

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

What is the FDA product code for TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE?

The FDA product code for TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE is DTL.

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Related Devices (Code: DTL)

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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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