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FDA 510(k)

BAHA CORDELLE II

K-Number: K080363 · 2008-04-10

ApplicantCochlear Bone Anchored Systems AB
Decision Date2008-04-10
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BAHA CORDELLE II is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Bone Anchored Systems AB. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080363. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAHA CORDELLE II?

BAHA CORDELLE II is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Cochlear Bone Anchored Systems AB. The 510(k) number is K080363.

When did BAHA CORDELLE II receive FDA 510(k) clearance?

BAHA CORDELLE II received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080363.

Who is the listed applicant for BAHA CORDELLE II?

The FDA 510(k) record lists Cochlear Bone Anchored Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAHA CORDELLE II?

The FDA product code for BAHA CORDELLE II is MAH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cochlear Bone Anchored Systems AB 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.

K090720COCHLEAR BAHA BP100

Related Devices (Code: MAH)

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.

K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical ABK203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK182116BA310 Abutment, BIA310 Implant/AbutmentCochlear AmericasK152820Ponto Bone Anchored Hearing SystemOticon Medical ABK121317COCHLEAR BAHA IMPLANT SYSTEMCochlear AmericasK121228PONTO BONE ANCHORED HEARING SYSTEMOticon Medical AB

Official Source

View on FDA Database →

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

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