Company ยท US
Aptus Endosystems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2014. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OTD | Endovascular Suturing System | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2014 | K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE Aptus Endosystems | OTD |
| Feb 6, 2014 | K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH Aptus Endosystems, Inc. | OTD |
| Apr 12, 2013 | K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM Aptus Endosystems, Inc. | OTD |
| Aug 8, 2012 | K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH Aptus Endosystems, Inc. | OTD |
| Nov 21, 2011 | DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE Aptus Endosystems, Inc. | OTD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||