The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Phycon All Silicone Balloon Catheter.
| Device ID | K894883 |
| 510k Number | K894883 |
| Device Name: | PHYCON ALL SILICONE BALLOON CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | VITAID, LTD. P.O. BOX 123 POSTAL STATION S., TORONTO Ontario, Canada, CA M5m 4l6 |
| Contact | William G Stewart |
| Correspondent | William G Stewart VITAID, LTD. P.O. BOX 123 POSTAL STATION S., TORONTO Ontario, Canada, CA M5m 4l6 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1990-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04544050056243 | K894883 | 000 |