The following data is part of a premarket notification filed by Needletech Products, Inc. with the FDA for Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013.
| Device ID | K031173 |
| 510k Number | K031173 |
| Device Name: | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 |
| Classification | Guide, Needle, Surgical |
| Applicant | NEEDLETECH PRODUCTS, INC. 81 WEST ST. Attleboro, MA 02703 |
| Contact | Rick Tripp |
| Correspondent | Rick Tripp NEEDLETECH PRODUCTS, INC. 81 WEST ST. Attleboro, MA 02703 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-07-23 |
| Summary: | summary |