The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Opti-plast Xl 5.5 F Pta Catheter.
| Device ID | K970725 |
| 510k Number | K970725 |
| Device Name: | OPTI-PLAST XL 5.5 F PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | Janet Shaw |
| Correspondent | Janet Shaw VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-05-09 |
| Summary: | summary |