The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Dual Lumen Catheter For Chronic Vascular Access.
| Device ID | K892926 |
| 510k Number | K892926 |
| Device Name: | DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Contact | Katherine Crewe |
| Correspondent | Katherine Crewe VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-12-05 |