FDA 510(k)

ViewFlex X ICE Catheter, Sensor Enabled

K-Number: K251231 · 2025-05-20

Decision Date2025-05-20

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ViewFlex X ICE Catheter, Sensor Enabled is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-05-20 under approval number K251231. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewFlex X ICE Catheter, Sensor Enabled?

ViewFlex X ICE Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2025-05-20. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K251231.

When was ViewFlex X ICE Catheter, Sensor Enabled approved by the FDA?

ViewFlex X ICE Catheter, Sensor Enabled received FDA 510(k) clearance on 2025-05-20, under approval number K251231.

What company makes ViewFlex X ICE Catheter, Sensor Enabled?

ViewFlex X ICE Catheter, Sensor Enabled is manufactured by ABBOTT MEDICAL.

What is the FDA product code for ViewFlex X ICE Catheter, Sensor Enabled?

The FDA product code for ViewFlex X ICE Catheter, Sensor Enabled is OBJ.

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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.