The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Steerable Torque Guide Wire.
| Device ID | K863178 |
| 510k Number | K863178 |
| Device Name: | UMI STEERABLE TORQUE GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-18 |
| Decision Date | 1986-09-19 |