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FDA 510(k)

CHARTIS CATHETER MODEL CHR-CA-12.0

K-Number: K111522 · 2011-09-29

ApplicantPulmonx, Inc.
Decision Date2011-09-29
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CHARTIS CATHETER MODEL CHR-CA-12.0 is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx, Inc.. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111522. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARTIS CATHETER MODEL CHR-CA-12.0?

CHARTIS CATHETER MODEL CHR-CA-12.0 is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Pulmonx, Inc.. The 510(k) number is K111522.

When did CHARTIS CATHETER MODEL CHR-CA-12.0 receive FDA 510(k) clearance?

CHARTIS CATHETER MODEL CHR-CA-12.0 received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111522.

Who is the listed applicant for CHARTIS CATHETER MODEL CHR-CA-12.0?

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

What is the FDA product code for CHARTIS CATHETER MODEL CHR-CA-12.0?

The FDA product code for CHARTIS CATHETER MODEL CHR-CA-12.0 is CBI.

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 Pulmonx, 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.

K111764CHARTIS CONSOLEK083883CHARTIS CATHETERK083199CHARTIS CONSOLE

Related Devices (Code: CBI)

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.

K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.K253096Chartis Precision CatheterPulmonx CorporationK232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.K222340Chartis Precision CatheterPulmonx CorporationK201026sOLVe TubeHytek Medical, 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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