Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter— 510(k) K180182
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K180182 for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter, Substantially Equivalent on 2018-09-14. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code EYB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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