UROMAX ULTRA BALLOON DILATATION CATHETER— 510(k) K130804
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K130804 for UROMAX ULTRA BALLOON DILATATION CATHETER, Substantially Equivalent on 2013-05-22. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code EZN
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- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K190612 — EQUINOX Balloon Dilatation Catheter
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
More clearances from Boston Scientific Corporation
view allAdverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
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 K130804
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 K130804.
Data sourced from openFDA. This site is unofficial and independent of the FDA.