The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Softrac-pta Peripheral Dilatation Catheter.
| Device ID | K882826 |
| 510k Number | K882826 |
| Device Name: | SOFTRAC-PTA PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Howard B Wittels |
| Correspondent | Howard B Wittels SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1989-01-24 |