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FDA 510(k)

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

K-Number: K990573 · 1999-03-11

ApplicantEstech, Inc.
Decision Date1999-03-11
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Estech, Inc.. It received FDA 510(k) clearance on 1999-03-11 under 510(k) number K990573. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA?

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA is a medical device that received FDA 510(k) clearance on 1999-03-11. The listed applicant is Estech, Inc.. The 510(k) number is K990573.

When did ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA receive FDA 510(k) clearance?

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA received FDA 510(k) clearance on 1999-03-11, under 510(k) number K990573.

Who is the listed applicant for ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA?

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 ARTERIAL REMOTE ACCESS PERFUSION CANNULA?

The FDA product code for ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA is DXC.

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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 SYSTEMK032632REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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