Panels › Cardiovascular › Product code OTD · Class 2
Endovascular Suturing System
Regulation 870.3460
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OTD
| Company | 510(k)s | Recalls |
|---|---|---|
| Aptus Endosystems | 5 | 0 |
| Medtronic Vascular, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2018 | K182957 | Heli-FX EndoAnchor System Medtronic Vascular, Inc. | OTD |
| Jun 13, 2017 | K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Medtronic Vascular, Inc. | OTD |
| 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 |
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