The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Translumbar Aortography Needle Catheter.
| Device ID | K884375 |
| 510k Number | K884375 |
| Device Name: | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER |
| Classification | Cannula, Catheter |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Brister, P.e. |
| Correspondent | Brister, P.e. ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1989-01-11 |