FDA 510(k)

BARD CRURASOFT PATCH, MODELS 0116003 & 0116001

K-Number: K022350 · 2002-08-23

Decision Date2002-08-23

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2002-08-23 under 510(k) number K022350. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD CRURASOFT PATCH, MODELS 0116003 & 0116001?

BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 is a medical device that received FDA 510(k) clearance on 2002-08-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K022350.

When did BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 receive FDA 510(k) clearance?

BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 received FDA 510(k) clearance on 2002-08-23, under 510(k) number K022350.

Who is the listed applicant for BARD CRURASOFT PATCH, MODELS 0116003 & 0116001?

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

What is the FDA product code for BARD CRURASOFT PATCH, MODELS 0116003 & 0116001?

The FDA product code for BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 is FTL.

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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.