COOK NEPHROSTOMY DILATION BALLOON CATHETER SET— 510(k) K024050
Substantially EquivalentCook Urological, Inc.
FDA 510(k) clearance K024050 for COOK NEPHROSTOMY DILATION BALLOON CATHETER SET, Substantially Equivalent on 2003-02-27. Applicant: Cook Urological, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Cook Urological, Inc.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
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More clearances from Cook Urological, Inc.
view allAdverse 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 K024050
K-number listed on FDA's recall record- Z-1237-2016 — UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
- Z-1238-2016 — Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024050.
Data sourced from openFDA. This site is unofficial and independent of the FDA.