The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Revised Labeling For Arterial Embolectomy Catheter.
| Device ID | K894681 |
| 510k Number | K894681 |
| Device Name: | REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-10-12 |