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FDA 510(k)

Oscar Peripheral Multifunctional Catheter system

K-Number: K214038 · 2022-07-06

ApplicantBiotronik, Inc.
Decision Date2022-07-06
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oscar Peripheral Multifunctional Catheter system is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-06 under approval number K214038. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oscar Peripheral Multifunctional Catheter system?

Oscar Peripheral Multifunctional Catheter system is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Biotronik, Inc.. The 510(k) number is K214038.

When was Oscar Peripheral Multifunctional Catheter system approved by the FDA?

Oscar Peripheral Multifunctional Catheter system received FDA 510(k) clearance on 2022-07-06, under approval number K214038.

What company makes Oscar Peripheral Multifunctional Catheter system?

Oscar Peripheral Multifunctional Catheter system is manufactured by Biotronik, Inc..

What is the FDA product code for Oscar Peripheral Multifunctional Catheter system?

The FDA product code for Oscar Peripheral Multifunctional Catheter system is LIT.

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Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

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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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