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FDA 510(k)

MBA

K-Number: K993057 · 1999-10-05

ApplicantMerit Medical Systems, Inc.
Decision Date1999-10-05
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MBA is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-10-05 under 510(k) number K993057. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MBA?

MBA is a medical device that received FDA 510(k) clearance on 1999-10-05. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K993057.

When did MBA receive FDA 510(k) clearance?

MBA received FDA 510(k) clearance on 1999-10-05, under 510(k) number K993057.

Who is the listed applicant for MBA?

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

What is the FDA product code for MBA?

The FDA product code for MBA is DTL.

Related PubMed Literature

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.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 41839575A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery ()PMID: 38569929Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.International journal of spine surgery ()

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Related Devices (Code: DTL)

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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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