The following data is part of a premarket notification filed by Scimed Peripheral Interventions with the FDA for Scimed Strike Steerable Guide Wire.
| Device ID | K934359 |
| 510k Number | K934359 |
| Device Name: | SCIMED STRIKE STEERABLE GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED PERIPHERAL INTERVENTIONS 2905 NORTHWEST BLVD., SUITE 60 Plymouth, MN 55441 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED PERIPHERAL INTERVENTIONS 2905 NORTHWEST BLVD., SUITE 60 Plymouth, MN 55441 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1993-10-07 |