FDA 510(k)

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

K-Number: K080500 · 2008-03-13

Decision Date2008-03-13

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 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 2008-03-13 under 510(k) number K080500. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7?

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K080500.

When did MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 receive FDA 510(k) clearance?

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 received FDA 510(k) clearance on 2008-03-13, under 510(k) number K080500.

Who is the listed applicant for MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7?

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 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7?

The FDA product code for MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 is DYB.

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Other records listing Acumen Medical, Inc. as applicant

K083855MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 K070396MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 K070051ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM K070197ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY K062145MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 K0620847F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67

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Related Devices (Code: DYB)

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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.