K042016 is an FDA 510(k) clearance for the DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Datascope Corp. (Manwah, US). The FDA issued a Cleared decision on September 23, 2004, 58 days after receiving the submission on July 27, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K042016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2004 |
| Decision Date | September 23, 2004 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MSD - Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |