The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Hemostasis Valve.
| Device ID | K895214 |
| 510k Number | K895214 |
| Device Name: | HEMOSTASIS VALVE |
| Classification | Introducer, Catheter |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Robert P Cooper |
| Correspondent | Robert P Cooper APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-18 |
| Decision Date | 1989-11-14 |