FDA 510(k)

BD Saf-T-Intima Subcutaneous Catheter System

K-Number: K251422 · 2025-10-08

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.

Decision Date2025-10-08

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Saf-T-Intima Subcutaneous Catheter System is a medical device manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-10-08 under approval number K251422. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Saf-T-Intima Subcutaneous Catheter System?

BD Saf-T-Intima Subcutaneous Catheter System is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K251422.

When was BD Saf-T-Intima Subcutaneous Catheter System approved by the FDA?

BD Saf-T-Intima Subcutaneous Catheter System received FDA 510(k) clearance on 2025-10-08, under approval number K251422.

What company makes BD Saf-T-Intima Subcutaneous Catheter System?

BD Saf-T-Intima Subcutaneous Catheter System is manufactured by Becton Dickinson Infusion Therapy Systems, Inc..

What is the FDA product code for BD Saf-T-Intima Subcutaneous Catheter System?

The FDA product code for BD Saf-T-Intima Subcutaneous Catheter System is FOZ.

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Related Devices (Code: FOZ)

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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.