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FDA 510(k)

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

K-Number: K221826 · 2022-12-21

ApplicantBecton, Dickinson and Company
Decision Date2022-12-21
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-12-21 under approval number K221826. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)?

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K221826.

When was BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) approved by the FDA?

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) received FDA 510(k) clearance on 2022-12-21, under approval number K221826.

What company makes BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)?

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)?

The FDA product code for BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) is JTN.

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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.

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