The following data is part of a premarket notification filed by Scimed Peripheral Interventions with the FDA for Scimed Viper Pta Catheter With Bioslide Hydrophilic Coating.
| Device ID | K935501 |
| 510k Number | K935501 |
| Device Name: | SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCIMED PERIPHERAL INTERVENTIONS 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 -2644 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED PERIPHERAL INTERVENTIONS 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 -2644 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-01-27 |