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FDA 510(k)

ViewFlex Xtra ICE Catheter

K-Number: K223077 · 2022-12-07

ApplicantIrvine Biomedical, A St. Jude Medical Company
Decision Date2022-12-07
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViewFlex Xtra ICE Catheter is a medical device manufactured by Irvine Biomedical, A St. Jude Medical Company. It received FDA 510(k) clearance on 2022-12-07 under approval number K223077. 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 Xtra ICE Catheter?

ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Irvine Biomedical, A St. Jude Medical Company. The 510(k) number is K223077.

When was ViewFlex Xtra ICE Catheter approved by the FDA?

ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2022-12-07, under approval number K223077.

What company makes ViewFlex Xtra ICE Catheter?

ViewFlex Xtra ICE Catheter is manufactured by Irvine Biomedical, A St. Jude Medical Company.

What is the FDA product code for ViewFlex Xtra ICE Catheter?

The FDA product code for ViewFlex Xtra ICE Catheter is OBJ.

Related Devices (Code: 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.

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