The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Equipment Support Carts Esc-002 & Escb-02.
| Device ID | K892446 |
| 510k Number | K892446 |
| Device Name: | SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Louis J Mazzarese |
| Correspondent | Louis J Mazzarese SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-07-14 |