The following data is part of a premarket notification filed by Argon Medical Devices, Inc with the FDA for Firststic N Introducer.
| Device ID | K141969 |
| 510k Number | K141969 |
| Device Name: | FIRSTSTIC N INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ARGON MEDICAL DEVICES, INC 1445 FLAT CREEK ROAD Athens, TX 75751 |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang ARGON MEDICAL DEVICES, INC 1445 FLAT CREEK ROAD Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2014-12-19 |
| Summary: | summary |