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FDA 510(k)

Abiomed 14Fr Low Profile Introducer Kit

K-Number: K241708 · 2024-08-06

ApplicantAbiomed, Inc.
Decision Date2024-08-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Abiomed 14Fr Low Profile Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2024-08-06 under 510(k) number K241708. 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 Abiomed 14Fr Low Profile Introducer Kit?

Abiomed 14Fr Low Profile Introducer Kit is a medical device that received FDA 510(k) clearance on 2024-08-06. The listed applicant is Abiomed, Inc.. The 510(k) number is K241708.

When did Abiomed 14Fr Low Profile Introducer Kit receive FDA 510(k) clearance?

Abiomed 14Fr Low Profile Introducer Kit received FDA 510(k) clearance on 2024-08-06, under 510(k) number K241708.

Who is the listed applicant for Abiomed 14Fr Low Profile Introducer Kit?

The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Abiomed 14Fr Low Profile Introducer Kit?

The FDA product code for Abiomed 14Fr Low Profile Introducer Kit is DYB.

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Other records listing Abiomed, 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.

PMA P140003Temporary non-roller type left heart support blood pumpPMA P170011Temporary non-roller type right heart support blood pumpK25276614Fr Low Profile Introducer KitK221294preCARDIA Occlusion SystemK223161OXY-1 SystemK222113Abiomed 14Fr Low Profile Introducer Set

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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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