The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Opti-plast 5f Pta Catheters Oven Curing Procedure.
| Device ID | K911639 |
| 510k Number | K911639 |
| Device Name: | OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Contact | Marco A Guillen |
| Correspondent | Marco A Guillen VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-20 |
| Decision Date | 1991-06-11 |