The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Torque Device.
| Device ID | K922536 |
| 510k Number | K922536 |
| Device Name: | TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Bob Everett |
| Correspondent | Bob Everett PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1992-12-10 |