Company ยท US
Endocardial Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2004. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2004 | K042493 | ENSITE SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. | DQK |
| Oct 30, 2003 | K033211 | ENSITE SYSTEM Endocardial Solutions, Inc. | DQK |
| Apr 22, 2003 | K030129 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. | DQK |
| Sep 28, 2001 | K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. | MTD |
| Jun 7, 2000 | K001437 | ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. | DQK |
| Jan 5, 2000 | K993376 | ENSTYLET MODELS EC0010, EC0020 Endocardial Solutions, Inc. | DRB |
| Dec 2, 1999 | K992479 | ENSITE 3000 SYSTEM Endocardial Solutions, Inc. | DQK |
| Apr 21, 1999 | K983456 | ENSITE 3000 SYSTEM Endocardial Solutions, Inc. | MTD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||