The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Galt Medical Guidewire.
| Device ID | K031916 |
| 510k Number | K031916 |
| Device Name: | GALT MEDICAL GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GALT MEDICAL CORP. 2475 MERRITT DR. Garland, TX 75041 |
| Contact | David Catlin |
| Correspondent | David Catlin GALT MEDICAL CORP. 2475 MERRITT DR. Garland, TX 75041 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-20 |
| Decision Date | 2003-07-17 |
| Summary: | summary |