The following data is part of a premarket notification filed by N-s Medical Products with the FDA for Tru-trac Torque Guidewire.
| Device ID | K880288 |
| 510k Number | K880288 |
| Device Name: | TRU-TRAC TORQUE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
| Contact | Keith L Stahl |
| Correspondent | Keith L Stahl N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333003505 | K880288 | 000 |
| 20886333003499 | K880288 | 000 |