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)

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

K-Number: K112586 · 2011-10-18

ApplicantBecton, Dickinson and Company (BD)
Decision Date2011-10-18
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company (BD). It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K112586. 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 CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)?

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Becton, Dickinson and Company (BD). The 510(k) number is K112586.

When did CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) receive FDA 510(k) clearance?

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) received FDA 510(k) clearance on 2011-10-18, under 510(k) number K112586.

Who is the listed applicant for CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)?

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

What is the FDA product code for CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)?

The FDA product code for CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Becton, Dickinson and Company (BD) 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.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)K111366BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEMK110105BD PEN NEEDLEK091292BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771

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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy DiagnosticsK261781Thermo 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 Diagnostics

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.

↑