In-Ka Ureteral Balloon Dilatation Catheter— 510(k) K201007
UnknownColoplast Corp.
FDA 510(k) clearance K201007 for In-Ka Ureteral Balloon Dilatation Catheter, Unknown on 2020-06-11. Applicant: Coloplast Corp.. Device class: 2.
Clearance details
- Applicant
- Coloplast Corp.
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code EZN
view all- K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter
- 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
- K190612 — EQUINOX Balloon Dilatation Catheter
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
- K180756 — Safety Wire Guide Introducer
More clearances from Coloplast Corp.
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.