The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Galtstick Introducer System.
| Device ID | K071330 |
| 510k Number | K071330 |
| Device Name: | GALTSTICK INTRODUCER SYSTEM |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | GALT MEDICAL CORP. 2220 MERRITT DR. Garland, TX 75041 |
| Contact | David Catlin |
| Correspondent | David Catlin GALT MEDICAL CORP. 2220 MERRITT DR. Garland, TX 75041 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-11 |
| Decision Date | 2007-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05711055001892 | K071330 | 000 |
| M20679620 | K071330 | 000 |
| M20679610 | K071330 | 000 |
| M20679600 | K071330 | 000 |
| 20841156105959 | K071330 | 000 |
| 20841156105935 | K071330 | 000 |
| 20841156105911 | K071330 | 000 |
| 20841156105904 | K071330 | 000 |
| 20841156105942 | K071330 | 000 |
| 20841156105928 | K071330 | 000 |
| 25711055001834 | K071330 | 000 |
| 25711055001827 | K071330 | 000 |
| 25711055001810 | K071330 | 000 |
| M20679640 | K071330 | 000 |
| M20679650 | K071330 | 000 |
| 05711055001885 | K071330 | 000 |
| 05711055001878 | K071330 | 000 |
| 05711055001861 | K071330 | 000 |
| 05711055001854 | K071330 | 000 |
| 05711055001847 | K071330 | 000 |
| 05711055001830 | K071330 | 000 |
| 05711055001823 | K071330 | 000 |
| 05711055001816 | K071330 | 000 |
| 05711055001809 | K071330 | 000 |
| 05711055001793 | K071330 | 000 |
| 05711055001762 | K071330 | 000 |
| M20679710 | K071330 | 000 |
| 25711055001766 | K071330 | 000 |