The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for 3f And 4f Irrigation Embolectomy Catheters.
| Device ID | K897184 |
| 510k Number | K897184 |
| Device Name: | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS |
| Classification | Catheter, Embolectomy |
| Applicant | CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-28 |
| Decision Date | 1990-03-14 |