NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER— 510(k) K121614
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K121614 for NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER, Substantially Equivalent on 2012-09-18. Applicant: Boston Scientific Corp. Device class: Unclassified.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, 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 Boston Scientific Corp
view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
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 K121614
K-number listed on FDA's recall record- Z-2535-2025 — Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
- Z-1672-2013 — NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
- Z-1673-2013 — NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121614.
Data sourced from openFDA. This site is unofficial and independent of the FDA.