The following data is part of a premarket notification filed by Needletech Products, Inc. with the FDA for Galt Tork, 0.010 To 0.020 Inches (yellow), Galt Tork, 0.025 To 0.040 Inches (orange).
| Device ID | K143252 |
| 510k Number | K143252 |
| Device Name: | Galt Tork, 0.010 To 0.020 Inches (yellow), Galt Tork, 0.025 To 0.040 Inches (orange) |
| Classification | Wire, Guide, Catheter |
| Applicant | NEEDLETECH PRODUCTS, INC. 452 John L. Dietsch Blvd. North Attleboro, MA 02763 |
| Contact | Dennis Shay |
| Correspondent | Dennis Shay NEEDLETECH PRODUCTS, INC. 452 John L. Dietsch Blvd. North Attleboro, MA 02763 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-04-23 |
| Summary: | summary |