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FDA 510(k)

MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69

K-Number: K033989 · 2004-01-22

ApplicantMedtronic Inc. Cardiac Rhythm Management
Decision Date2004-01-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Inc. Cardiac Rhythm Management. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K033989. 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 MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69?

MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Medtronic Inc. Cardiac Rhythm Management. The 510(k) number is K033989.

When did MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 receive FDA 510(k) clearance?

MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 received FDA 510(k) clearance on 2004-01-22, under 510(k) number K033989.

Who is the listed applicant for MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69?

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

What is the FDA product code for MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69?

The FDA product code for MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 is DQY.

Related Clinical Trials

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Other records listing Medtronic Inc. Cardiac Rhythm Management as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063210ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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