FDA 510(k)

CELSITE VENOUS ACCESS SYSTEM OTW

K-Number: K954297 · 1995-12-01

Decision Date1995-12-01

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CELSITE VENOUS ACCESS SYSTEM OTW 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 1995-12-01 under 510(k) number K954297. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELSITE VENOUS ACCESS SYSTEM OTW?

CELSITE VENOUS ACCESS SYSTEM OTW is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K954297.

When did CELSITE VENOUS ACCESS SYSTEM OTW receive FDA 510(k) clearance?

CELSITE VENOUS ACCESS SYSTEM OTW received FDA 510(k) clearance on 1995-12-01, under 510(k) number K954297.

Who is the listed applicant for CELSITE VENOUS ACCESS SYSTEM OTW?

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 CELSITE VENOUS ACCESS SYSTEM OTW?

The FDA product code for CELSITE VENOUS ACCESS SYSTEM OTW is LJT.

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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.