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FDA 510(k)

ESTECH CLEARVIEW MV ATRIAL DEPRESSOR

K-Number: K053021 · 2006-01-26

ApplicantEstech, Inc.
Decision Date2006-01-26
Product CodeDTS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESTECH CLEARVIEW MV ATRIAL DEPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Estech, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K053021. The device is classified under product code DTS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH CLEARVIEW MV ATRIAL DEPRESSOR?

ESTECH CLEARVIEW MV ATRIAL DEPRESSOR is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Estech, Inc.. The 510(k) number is K053021.

When did ESTECH CLEARVIEW MV ATRIAL DEPRESSOR receive FDA 510(k) clearance?

ESTECH CLEARVIEW MV ATRIAL DEPRESSOR received FDA 510(k) clearance on 2006-01-26, under 510(k) number K053021.

Who is the listed applicant for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR?

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

What is the FDA product code for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR?

The FDA product code for ESTECH CLEARVIEW MV ATRIAL DEPRESSOR is DTS.

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Other records listing Estech, 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.

K133017ESTECH COBRA(R) GENESIS BIPOLAR CLAMPK052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULAK051749COBRA SURGICAL SYSTEMK041599COBRA ADHERE SURGICAL SYSTEMK032632REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCHK990573ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

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Related Devices (Code: DTS)

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.

K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp.K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products

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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