K884375 is an FDA 510(k) clearance for the TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on January 11, 1989, 85 days after receiving the submission on October 18, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K884375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1988 |
| Decision Date | January 11, 1989 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |