The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Torque Device For A Guide Wire.
| Device ID | K910969 |
| 510k Number | K910969 |
| Device Name: | TORQUE DEVICE FOR A GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TERUMO CORP. 2100 COTTONTAIL LN. Somerset, NJ 08873 |
| Contact | Mike Ichiyanagi |
| Correspondent | Mike Ichiyanagi TERUMO CORP. 2100 COTTONTAIL LN. Somerset, NJ 08873 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-05-16 |