APTUS HELI-FX AORTIC SECUREMENT SYSTEM
FDA 510(k) clearance K130677 · decided 2013-04-12
Clearance details
- K-number
- K130677
- Device name
- APTUS HELI-FX AORTIC SECUREMENT SYSTEM
- Applicant
- Aptus Endosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-13
- Decision date
- 2013-04-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OTD
- Device class
- 2
- Regulation number
- 870.3460
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (K141041) | Aptus Endosystems | 2014-05-16 |
| APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH (K140036) | Aptus Endosystems, Inc. | 2014-02-06 |
| APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (K121168) | Aptus Endosystems, Inc. | 2012-08-08 |
| APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE (DEN100026) | Aptus Endosystems, Inc. | 2011-11-21 |
Recalls involving this device
No recalls on record reference this clearance.