The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fogarty Arterial Embolectomy Ii Catheter.
| Device ID | K901625 |
| 510k Number | K901625 |
| Device Name: | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-09 |
| Decision Date | 1990-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103043044 | K901625 | 000 |
| 00690103042429 | K901625 | 000 |
| 00690103042412 | K901625 | 000 |