The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Embolectomy Catheter(modified).
| Device ID | K881455 |
| 510k Number | K881455 |
| Device Name: | EMBOLECTOMY CATHETER(MODIFIED) |
| Classification | Catheter, Embolectomy |
| Applicant | CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
| Contact | Sattar Saudagar |
| Correspondent | Sattar Saudagar 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 | 1988-04-06 |
| Decision Date | 1988-06-15 |