X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER— 510(k) K063632
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K063632 for X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER, Substantially Equivalent on 2007-01-05. Applicant: C.R. Bard, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Covington, GA, US
Recent devices under product code LJE
view all- K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit
- K222705 — Introducer Needle
- K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
- K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
More clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
Adverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K063632
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063632.
Data sourced from openFDA. This site is unofficial and independent of the FDA.