The following data is part of a premarket notification filed by Argon Medical Devices Inc. with the FDA for Argon Continuous Flush Device.
| Device ID | K070384 |
| 510k Number | K070384 |
| Device Name: | ARGON CONTINUOUS FLUSH DEVICE |
| Classification | Catheter, Continuous Flush |
| Applicant | ARGON MEDICAL DEVICES INC. 1445 FLAT CREEK RD. Athens, TX 75751 |
| Contact | Amy Windham |
| Correspondent | Amy Windham ARGON MEDICAL DEVICES INC. 1445 FLAT CREEK RD. Athens, TX 75751 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-09 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333201574 | K070384 | 000 |
| 20886333201567 | K070384 | 000 |