FDA 510(k) Search

K Number

K250772

Device Name

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

Manufacturer

Surgical Instrument Service and Savings Inc.

Date Cleared

2025-07-11

Product Code

NLH

Regulation Number

870.1220

Intended Use

PDF not available yet

Device Description

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More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

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Class Advise Committee

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Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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