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FDA 510(k)

APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH

K-Number: K121168 · 2012-08-08

ApplicantAptus Endosystems, Inc.
Decision Date2012-08-08
Product CodeOTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH is the device name listed in this FDA 510(k) record. The listed applicant is Aptus Endosystems, Inc.. It received FDA 510(k) clearance on 2012-08-08 under 510(k) number K121168. The device is classified under product code OTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH?

APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH is a medical device that received FDA 510(k) clearance on 2012-08-08. The listed applicant is Aptus Endosystems, Inc.. The 510(k) number is K121168.

When did APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH receive FDA 510(k) clearance?

APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH received FDA 510(k) clearance on 2012-08-08, under 510(k) number K121168.

Who is the listed applicant for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH?

The FDA 510(k) record lists Aptus Endosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH?

The FDA product code for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH is OTD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Aptus Endosystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEM

Related Devices (Code: OTD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc.K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEMAptus Endosystems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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