K180530 is an FDA 510(k) clearance for the Imager II Urology Torque Catheter. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on April 10, 2018, 41 days after receiving the submission on February 28, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K180530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2018 |
| Decision Date | April 10, 2018 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |