K203767 is an FDA 510(k) clearance for the Pristine Long-Term Hemodialysis Catheter. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by C B Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on April 2, 2021, 100 days after receiving the submission on December 23, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K203767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 23, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD - Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |