Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-12-21 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K221826.

When did BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) receive FDA 510(k) clearance?

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

Who is the listed applicant for BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05957406SMART TRENDS StudyCOMPLETEDNCT06492746Personal BP - CAI StudyRECRUITINGNCT07148323HemoSphere Alta StudyRECRUITINGNCT07216573The Continuity StudyRECRUITINGNCT07317648ClearSight NextGen1 StudyCOMPLETED

Other records listing Becton, Dickinson and Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeK260184Onclarity™ Self-Collection KitK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

View all 100 devices →

Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchem

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.

↑