The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fogarty(r) Thru-lumen Embolectomy Catheter.
| Device ID | K892410 |
| 510k Number | K892410 |
| Device Name: | FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | J Krattenmaker |
| Correspondent | J Krattenmaker BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103177657 | K892410 | 000 |
| 00690103043464 | K892410 | 000 |
| 00690103043488 | K892410 | 000 |
| 00690103043495 | K892410 | 000 |
| 00690103043501 | K892410 | 000 |
| 00690103043518 | K892410 | 000 |
| 00690103043532 | K892410 | 000 |
| 00690103043549 | K892410 | 000 |
| 00690103043556 | K892410 | 000 |
| 00690103043457 | K892410 | 000 |