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FDA 510(k)

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

K-Number: K070051 · 2007-04-06

ApplicantAcumen Medical, Inc.
Decision Date2007-04-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acumen Medical, Inc.. It received FDA 510(k) clearance on 2007-04-06 under 510(k) number K070051. 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 ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM?

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K070051.

When did ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM receive FDA 510(k) clearance?

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM received FDA 510(k) clearance on 2007-04-06, under 510(k) number K070051.

Who is the listed applicant for ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM?

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

What is the FDA product code for ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM?

The FDA product code for ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM is DQY.

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Other records listing Acumen Medical, 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.

K083855MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59K080500MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7K070396MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45K070197ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STYK062145MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90K0620847F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67

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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, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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