The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Catheter Introducer Sheath.
| Device ID | K890766 |
| 510k Number | K890766 |
| Device Name: | CATHETER INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | John Gehrich |
| Correspondent | John Gehrich 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 | 1989-02-15 |
| Decision Date | 1989-09-18 |