FDA 510(k)

B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT

K-Number: K955381 · 1996-02-21

Decision Date1996-02-21

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT 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 1996-02-21 under 510(k) number K955381. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT?

B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT is a medical device that received FDA 510(k) clearance on 1996-02-21. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K955381.

When did B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT receive FDA 510(k) clearance?

B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT received FDA 510(k) clearance on 1996-02-21, under 510(k) number K955381.

Who is the listed applicant for B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT?

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 B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT?

The FDA product code for B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.