The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Evans, Vas-cath Epidural Needle & Catheter.
| Device ID | K850009 |
| 510k Number | K850009 |
| Device Name: | EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Contact | Kamal Kalwani |
| Correspondent | Kamal Kalwani VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-02 |
| Decision Date | 1985-05-13 |