FDA 510(k)

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

K-Number: K051515 · 2005-09-01

Decision Date2005-09-01

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 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 2005-09-01 under 510(k) number K051515. 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 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65?

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 is a medical device that received FDA 510(k) clearance on 2005-09-01. The listed applicant is Acumen Medical, Inc.. The 510(k) number is K051515.

When did MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 receive FDA 510(k) clearance?

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 received FDA 510(k) clearance on 2005-09-01, under 510(k) number K051515.

Who is the listed applicant for MODIFIED ACUMEN SHEATH, MODEL TTW 10-65?

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 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65?

The FDA product code for MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 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 K080500MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 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

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Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo 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.