URETERAL DILATION SET— 510(k) K851144
Substantially EquivalentVan-Tec, Inc.
FDA 510(k) clearance K851144 for URETERAL DILATION SET, Substantially Equivalent on 1985-04-09. Applicant: Van-Tec, Inc.. Device class: 2.
Clearance details
- Applicant
- Van-Tec, Inc.
- 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
- Spencer, IN, US
Recent devices under product code EZN
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- K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K190612 — EQUINOX Balloon Dilatation Catheter
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
More clearances from Van-Tec, Inc.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.