Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Abiomed 23 Fr Sheath

K-Number: K201116 · 2020-06-15

ApplicantAbiomed, Inc.
Decision Date2020-06-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Abiomed 23 Fr Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2020-06-15 under 510(k) number K201116. 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 23 Fr Sheath?

Abiomed 23 Fr Sheath is a medical device that received FDA 510(k) clearance on 2020-06-15. The listed applicant is Abiomed, Inc.. The 510(k) number is K201116.

When did Abiomed 23 Fr Sheath receive FDA 510(k) clearance?

Abiomed 23 Fr Sheath received FDA 510(k) clearance on 2020-06-15, under 510(k) number K201116.

Who is the listed applicant for Abiomed 23 Fr Sheath?

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 23 Fr Sheath?

The FDA product code for Abiomed 23 Fr Sheath is DYB.

Related Clinical Trials

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.

NCT04763200Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular FunctionACTIVE_NOT_RECRUITINGNCT05529654IMpella-Protected cArdiaC Surgery Trial (IMPACT)COMPLETEDNCT06964685Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic ShockRECRUITING

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 KitK241708Abiomed 14Fr Low Profile Introducer KitK221294preCARDIA Occlusion SystemK223161OXY-1 System

View all 11 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.

↑