Submission Details
| 510(k) Number | K070384 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 2007 |
| Decision Date | March 29, 2007 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ARGON CONTINUOUS FLUSH DEVICE
Mar 2007
Decision
48d
Days
Class 2
Risk
About This 510(k) Submission
K070384 is an FDA 510(k) clearance for the ARGON CONTINUOUS FLUSH DEVICE, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on March 29, 2007, 48 days after receiving the submission on February 9, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.
Device Classification
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1210 |
Manufacturer
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