The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Elite Hv Radial.
Device ID | K173287 |
510k Number | K173287 |
Device Name: | Elite HV Radial |
Classification | Introducer, Catheter |
Applicant | Galt Medical Corp. 2220 Merritt Drive Garland, TX 75087 |
Contact | David Derrick |
Correspondent | David Derrick Galt Medical Corp. 2220 Merritt Drive Garland, TX 75087 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-16 |
Decision Date | 2017-12-21 |
Summary: | summary |