K982326 is an FDA 510(k) clearance for the MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 12, 1999, 375 days after receiving the submission on July 2, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K982326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1998 |
| Decision Date | July 12, 1999 |
| Days to Decision | 375 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 |