Name: Predicase
Price: 199 USD

K-number	K252405
Device name	Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
Applicant	Surgical Instrument Service and Savings, Inc.
Product code	NLH
Device class	Class II
Decision date	Nov 26, 2025
Decision	Substantially Equivalent
Regulation	870.1220

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Everything you need for a 510(k) submission. Nothing you don't.