The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Peel-away Sheath(a Component Of Argon Introd Set).
| Device ID | K852880 |
| 510k Number | K852880 |
| Device Name: | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) |
| Classification | Introducer, Catheter |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Dave Meyers |
| Correspondent | Dave Meyers ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-08-29 |