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FDA 510(k)

CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508

K-Number: K042381 · 2004-12-28

ApplicantAcumen Medical, Inc.
Decision Date2004-12-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 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 2004-12-28 under 510(k) number K042381. 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 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508?

CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 is a medical device that received FDA 510(k) clearance on 2004-12-28. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K042381.

When did CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 receive FDA 510(k) clearance?

CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 received FDA 510(k) clearance on 2004-12-28, under 510(k) number K042381.

Who is the listed applicant for CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508?

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 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508?

The FDA product code for CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 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-6-45K070051ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEMK070197ACUMEN 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-10-64-90

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Related Devices (Code: DQY)

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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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