The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Softrac-pta(tm) Peripheral Dilatation Catheter.
| Device ID | K881197 |
| 510k Number | K881197 |
| Device Name: | SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Ann H Morrissey |
| Correspondent | Ann H Morrissey 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 | 1988-03-21 |
| Decision Date | 1988-05-16 |