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FDA 510(k)

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0

K-Number: K002116 · 2000-08-09

ApplicantMedical Device Consultants, Inc.
Decision Date2000-08-09
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 2000-08-09 under 510(k) number K002116. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0?

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K002116.

When did S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 receive FDA 510(k) clearance?

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 received FDA 510(k) clearance on 2000-08-09, under 510(k) number K002116.

Who is the listed applicant for S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0?

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

What is the FDA product code for S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0?

The FDA product code for S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 is DTQ.

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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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