The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Pressure Gauge Accessory Kit/dilatation.
| Device ID | K802261 |
| 510k Number | K802261 |
| Device Name: | PRESSURE GAUGE ACCESSORY KIT/DILATATION |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | STANCO MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-10-03 |