FDA 510(k)

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

Número K: K232037 · 2024-04-04

Data da decisão2024-04-04

Código do produtoPNE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232037. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Innovative Health, LLC. The 510(k) number is K232037.

When did Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath receive FDA 510(k) clearance?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232037.

Who is the listed applicant for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

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

What is the FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

The FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is PNE.

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Outros registros que listam Innovative Health, LLC como candidato(a)

K231015Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters K230376Reprocessed Agilis NxT Steerable Introducer K213584Reprocessed NRG Transseptal Needle K221854Reprocesses Umbilical Cable K210655Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K212165Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

Ver todos os 48 dispositivos →

Dispositivos Relacionados (Código: PNE)

K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K152090Reprocessed Steerable IntroducerSterilmed, Inc.

Fonte oficial

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