The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Inflation Device, Model Sm 2000.
| Device ID | K875064 |
| 510k Number | K875064 |
| Device Name: | SCIMED INFLATION DEVICE, MODEL SM 2000 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 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 | 1987-12-09 |
| Decision Date | 1988-02-29 |