The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for The Pilot Scimed Torque Device.
| Device ID | K896108 |
| 510k Number | K896108 |
| Device Name: | THE PILOT SCIMED TORQUE DEVICE |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Carroll Knost |
| Correspondent | Carroll Knost SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-23 |
| Decision Date | 1990-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H74902470012 | K896108 | 000 |
| 20193489078012 | K896108 | 000 |