FDA Product Code
FDA Product Code OTD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3460
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018-11-21 | Special | PDF ↗ |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | 2017-06-13 | Special | PDF ↗ |
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | Aptus Endosystems | 2014-05-16 | Special | PDF ↗ |
| K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH | Aptus Endosystems, Inc. | 2014-02-06 | Special | PDF ↗ |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | Aptus Endosystems, Inc. | 2013-04-12 | Special | PDF ↗ |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | Aptus Endosystems, Inc. | 2012-08-08 | Traditional | PDF ↗ |
| DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE | Aptus Endosystems, Inc. | 2011-11-21 | Post-NSE | — |
Product code OTD · Class II · Cardiovascular. Data: openFDA.