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FDA 510(k)

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH

K-Number: K032632 · 2003-10-22

ApplicantEstech, Inc.
Decision Date2003-10-22
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH is the device name listed in this FDA 510(k) record. The listed applicant is Estech, Inc.. It received FDA 510(k) clearance on 2003-10-22 under 510(k) number K032632. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH?

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH is a medical device that received FDA 510(k) clearance on 2003-10-22. The listed applicant is Estech, Inc.. The 510(k) number is K032632.

When did REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH receive FDA 510(k) clearance?

REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH received FDA 510(k) clearance on 2003-10-22, under 510(k) number K032632.

Who is the listed applicant for REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH?

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 REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH?

The FDA product code for REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH is DWF.

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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 CLAMPK053021ESTECH CLEARVIEW MV ATRIAL DEPRESSORK052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULAK051749COBRA SURGICAL SYSTEMK041599COBRA ADHERE SURGICAL SYSTEMK990573ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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