The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Galt Medical Guidewire.
Device ID | K021990 |
510k Number | K021990 |
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 | 2002-06-18 |
Decision Date | 2002-07-18 |
Summary: | summary |