The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Trac-wright System, Model Tw2.
| Device ID | K910594 |
| 510k Number | K910594 |
| Device Name: | TRAC-WRIGHT SYSTEM, MODEL TW2 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Mcgurk Burleson |
| Correspondent | Mcgurk Burleson DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-09-23 |