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FDA 510(k)

ENABLER-P CATHETER SYSTEM, MODEL 3000

K-Number: K092174 · 2009-12-30

ApplicantEndocross, Ltd.
Decision Date2009-12-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENABLER-P CATHETER SYSTEM, MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Endocross, Ltd.. It received FDA 510(k) clearance on 2009-12-30 under 510(k) number K092174. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENABLER-P CATHETER SYSTEM, MODEL 3000?

ENABLER-P CATHETER SYSTEM, MODEL 3000 is a medical device that received FDA 510(k) clearance on 2009-12-30. The listed applicant is Endocross, Ltd.. The 510(k) number is K092174.

When did ENABLER-P CATHETER SYSTEM, MODEL 3000 receive FDA 510(k) clearance?

ENABLER-P CATHETER SYSTEM, MODEL 3000 received FDA 510(k) clearance on 2009-12-30, under 510(k) number K092174.

Who is the listed applicant for ENABLER-P CATHETER SYSTEM, MODEL 3000?

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

What is the FDA product code for ENABLER-P CATHETER SYSTEM, MODEL 3000?

The FDA product code for ENABLER-P CATHETER SYSTEM, MODEL 3000 is DQY.

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.

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Other records listing Endocross, Ltd. 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.

K083833ENABLER-P CATHETER, 1000 PART NUMBER:1160K082339ENABLER-P SUPPORT CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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