Balloon Catheter and Balloon Ureteral Dilator Set— 510(k) K172588
UnknownCook Incorporated
FDA 510(k) clearance K172588 for Balloon Catheter and Balloon Ureteral Dilator Set, Unknown on 2018-04-19. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- 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
- Bloomington, IN, 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
- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K190612 — EQUINOX Balloon Dilatation Catheter
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
More clearances from Cook Incorporated
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.