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FDA 510(k)

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

K-Number: K063210 · 2007-03-15

ApplicantMedtronic Inc. Cardiac Rhythm Management
Decision Date2007-03-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 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 2007-03-15 under 510(k) number K063210. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488?

ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Medtronic Inc. Cardiac Rhythm Management. The 510(k) number is K063210.

When did ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 receive FDA 510(k) clearance?

ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 received FDA 510(k) clearance on 2007-03-15, under 510(k) number K063210.

Who is the listed applicant for ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488?

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 ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488?

The FDA product code for ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 is DQX.

Related Clinical Trials

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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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.

K033989MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69

Related Devices (Code: DQX)

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

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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