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FDA 510(k)

7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67

K-Number: K062084 · 2006-08-18

ApplicantAcumen Medical, Inc.
Decision Date2006-08-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 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 2006-08-18 under 510(k) number K062084. 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 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67?

7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K062084.

When did 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 receive FDA 510(k) clearance?

7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 received FDA 510(k) clearance on 2006-08-18, under 510(k) number K062084.

Who is the listed applicant for 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67?

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 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67?

The FDA product code for 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 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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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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