The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Trifusion Triple Lumen Infusion Catheter.
| Device ID | K895597 |
| 510k Number | K895597 |
| Device Name: | VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | H Crewe |
| Correspondent | H Crewe VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1990-09-12 |