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FDA 510(k)

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET

K-Number: K945396 · 1995-03-13

ApplicantB.Braun Medical, Inc.
Decision Date1995-03-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K945396. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET?

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K945396.

When did FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET receive FDA 510(k) clearance?

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET received FDA 510(k) clearance on 1995-03-13, under 510(k) number K945396.

Who is the listed applicant for FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET?

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

What is the FDA product code for FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET?

The FDA product code for FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET is DYB.

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Related Devices (Code: DYB)

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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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