The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Cathlab Silicone Arterial Embolectomy Catheter.
| Device ID | K905139 |
| 510k Number | K905139 |
| Device Name: | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | CATHLAB CORP. 17991 FITCH Irvine, CA 92714 |
| Contact | Daniel Lucas |
| Correspondent | Daniel Lucas CATHLAB CORP. 17991 FITCH 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 | 1990-11-09 |
| Decision Date | 1991-02-25 |