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FDA 510(k)

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

K-Number: K251654 · 2025-06-27

Decision Date2025-06-27
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is a medical device manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-06-27 under approval number K251654. 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 Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K251654.

When was BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter approved by the FDA?

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter received FDA 510(k) clearance on 2025-06-27, under approval number K251654.

What company makes BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is manufactured by Becton Dickinson Infusion Therapy Systems, Inc..

What is the FDA product code for BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

The FDA product code for BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is FOZ.

Other Devices by Becton Dickinson Infusion Therapy Systems, Inc.

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Related Devices (Code: FOZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.