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FDA 510(k)

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)

K-Number: K042850 · 2006-08-09

ApplicantStereotaxis, Inc.
Decision Date2006-08-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2006-08-09 under 510(k) number K042850. 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 CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)?

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) is a medical device that received FDA 510(k) clearance on 2006-08-09. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K042850.

When did CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) receive FDA 510(k) clearance?

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) received FDA 510(k) clearance on 2006-08-09, under 510(k) number K042850.

Who is the listed applicant for CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)?

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

What is the FDA product code for CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)?

The FDA product code for CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) 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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