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FDA 510(k)

SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM

K-Number: K060807 · 2006-04-24

ApplicantBiotronik, Inc.
Decision Date2006-04-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2006-04-24 under 510(k) number K060807. 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 SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM?

SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-24. The listed applicant is Biotronik, Inc.. The 510(k) number is K060807.

When did SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM receive FDA 510(k) clearance?

SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM received FDA 510(k) clearance on 2006-04-24, under 510(k) number K060807.

Who is the listed applicant for SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM?

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

What is the FDA product code for SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM?

The FDA product code for SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM is DQY.

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Other records listing Biotronik, Inc. as applicant

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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

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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