FDA 510(k)

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

K-Number: K080944 · 2008-10-23

Decision Date2008-10-23

Product CodeLJE

DecisionSubstantially Equivalent

Device Summary

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER 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 2008-10-23 under 510(k) number K080944. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER?

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K080944.

When did X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER receive FDA 510(k) clearance?

X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER received FDA 510(k) clearance on 2008-10-23, under 510(k) number K080944.

Who is the listed applicant for X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER?

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 X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER?

The FDA product code for X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER is LJE.

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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.