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FDA 510(k)

ACUMEN SINGLE-LUMEN DELIVERY SHEATH

K-Number: K053400 · 2006-06-19

ApplicantAcumen Medical, Inc.
Decision Date2006-06-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUMEN SINGLE-LUMEN DELIVERY SHEATH 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 2006-06-19 under 510(k) number K053400. 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 ACUMEN SINGLE-LUMEN DELIVERY SHEATH?

ACUMEN SINGLE-LUMEN DELIVERY SHEATH is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K053400.

When did ACUMEN SINGLE-LUMEN DELIVERY SHEATH receive FDA 510(k) clearance?

ACUMEN SINGLE-LUMEN DELIVERY SHEATH received FDA 510(k) clearance on 2006-06-19, under 510(k) number K053400.

Who is the listed applicant for ACUMEN SINGLE-LUMEN DELIVERY SHEATH?

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 SINGLE-LUMEN DELIVERY SHEATH?

The FDA product code for ACUMEN SINGLE-LUMEN DELIVERY SHEATH is DYB.

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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

View all 12 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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