The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Niagara Dual Lumen Catheter.
| Device ID | K965178 |
| 510k Number | K965178 |
| Device Name: | NIAGARA DUAL LUMEN CATHETER |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Contact | Dolores Mcgirr |
| Correspondent | Dolores Mcgirr VAS-CATH, INC. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-08-19 |
| Summary: | summary |