Aptus Endosystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Aptus Endosystems, Inc. makes
Aptus Endosystems, Inc. manufactures endovascular and endoluminal devices, including aortic security systems, deflectable guidewires, and endostaple applicators with cassettes. Their portfolio includes steerable endoguidance tools and specialized applicators designed for vascular and gastrointestinal procedures. The company also produces guide catheters with varying deflectable lengths for targeted interventions.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device standards. The manufacturer operates from the United States.
Catalogue
Aptus Heli-Fx Aortic Securement System Ref K130677
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Aptus Heli-Fx Ancillary Endoanchor Cassette Ref K141041
Regimes: 510(k) Registry: 510(k)Aptus Steerable Endoguide With Obturator, Aptus Endostaple Applier With Endostaple Cassette, Aptus Endostaple Cassette Ref DEN100026
Regimes: De Novo Registry: De NovoAptus 18Fr Helifx Guide-22 Deflectable Length Ref K121168
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aptus Endosystems, Inc. have in the registry?
The registry currently lists 5 devices for Aptus Endosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aptus Endosystems, Inc.'s devices?
Among its 5 most recently registered devices, Aptus Endosystems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Aptus Endosystems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Aptus Endosystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aptus Endosystems, Inc. in the registry?
The most recently registered devices listed for Aptus Endosystems, Inc. include APTUS HELI-FX AORTIC SECUREMENT SYSTEM, APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH, APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE and APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE.