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FDA 510(k)

SCOUTPRO HEMOSTATIC VALVE

K-Number: K101282 · 2010-07-21

ApplicantBiotronik, Inc.
Decision Date2010-07-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCOUTPRO HEMOSTATIC VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2010-07-21 under 510(k) number K101282. 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 HEMOSTATIC VALVE?

SCOUTPRO HEMOSTATIC VALVE is a medical device that received FDA 510(k) clearance on 2010-07-21. The listed applicant is Biotronik, Inc.. The 510(k) number is K101282.

When did SCOUTPRO HEMOSTATIC VALVE receive FDA 510(k) clearance?

SCOUTPRO HEMOSTATIC VALVE received FDA 510(k) clearance on 2010-07-21, under 510(k) number K101282.

Who is the listed applicant for SCOUTPRO HEMOSTATIC VALVE?

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 HEMOSTATIC VALVE?

The FDA product code for SCOUTPRO HEMOSTATIC VALVE is DQY.

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Related Devices (Code: DQY)

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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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