The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Catheter Balloon Dilator Pressure Gauge.
| Device ID | K895511 |
| 510k Number | K895511 |
| Device Name: | CATHETER BALLOON DILATOR PRESSURE GAUGE |
| Classification | Syringe, Balloon Inflation |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Clayton Koon |
| Correspondent | Clayton Koon ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1990-02-28 |