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FDA 510(k)

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

K-Number: K121006 · 2012-05-03

ApplicantSt Jude Medical
Decision Date2012-05-03
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K121006. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER?

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is St Jude Medical. The 510(k) number is K121006.

When did ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER received FDA 510(k) clearance on 2012-05-03, under 510(k) number K121006.

Who is the listed applicant for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER?

The FDA product code for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER is MTD.

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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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