K981994 is an FDA 510(k) clearance for the VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 3, 1998, 87 days after receiving the submission on June 8, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K981994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1998 |
| Decision Date | September 03, 1998 |
| Days to Decision | 87 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 |