The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Kadir Hi-torque Guide Wire.
| Device ID | K871297 |
| 510k Number | K871297 |
| Device Name: | KADIR HI-TORQUE GUIDE WIRE |
| Classification | Catheter, Urological |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | David J Meyers |
| Correspondent | David J Meyers ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-04-10 |