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FDA 510(k)

SYNCRUS INTERNAL CARDIOVERSION SYSTEM

K-Number: K020701 · 2002-05-24

ApplicantGuidant Corporation, Cardiac Surgery
Decision Date2002-05-24
Product CodeNHW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNCRUS INTERNAL CARDIOVERSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation, Cardiac Surgery. It received FDA 510(k) clearance on 2002-05-24 under 510(k) number K020701. The device is classified under product code NHW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCRUS INTERNAL CARDIOVERSION SYSTEM?

SYNCRUS INTERNAL CARDIOVERSION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Guidant Corporation, Cardiac Surgery. The 510(k) number is K020701.

When did SYNCRUS INTERNAL CARDIOVERSION SYSTEM receive FDA 510(k) clearance?

SYNCRUS INTERNAL CARDIOVERSION SYSTEM received FDA 510(k) clearance on 2002-05-24, under 510(k) number K020701.

Who is the listed applicant for SYNCRUS INTERNAL CARDIOVERSION SYSTEM?

The FDA 510(k) record lists Guidant Corporation, Cardiac Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCRUS INTERNAL CARDIOVERSION SYSTEM?

The FDA product code for SYNCRUS INTERNAL CARDIOVERSION SYSTEM is NHW.

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Other records listing Guidant Corporation, Cardiac Surgery 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.

K080169HEARTSTRING III PROXIMAL SEAL SYSTEMK041340GUIDANT MICROWAVE ABLATION SYSTEMK023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEMK023629ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200K022718VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002

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Related Devices (Code: NHW)

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.

K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEMGuidant Corporation, Cardiac Surgery

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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