The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Disposable Introducer Sheath.
| Device ID | K910079 |
| 510k Number | K910079 |
| Device Name: | DISPOSABLE INTRODUCER SHEATH |
| Classification | Instrument, Surgical, Disposable |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-02-27 |