Cleared Special

K080944 - X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

K080944 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
203d
Days
-
Risk

K080944 is an FDA 510(k) clearance for the X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K080944

510(k) Number K080944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date October 23, 2008
Days to Decision 203 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Modification to existing cleared device.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 53
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