The following data is part of a premarket notification filed by Argon Medical with the FDA for V-stick Vascular Access Set.
Device ID | K130730 |
510k Number | K130730 |
Device Name: | V-STICK VASCULAR ACCESS SET |
Classification | Introducer, Catheter |
Applicant | ARGON MEDICAL 3600 SW 47TH AVE Gainesville, FL 32608 |
Contact | Jennifer Bonacci |
Correspondent | Jennifer Bonacci ARGON MEDICAL 3600 SW 47TH AVE Gainesville, FL 32608 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-18 |
Decision Date | 2013-11-22 |
Summary: | summary |