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 Intelliport System

K-Number: K182092 · 2019-04-30

ApplicantBecton, Dickinson and Company
Decision Date2019-04-30
Product CodePHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Intelliport System 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 2019-04-30 under 510(k) number K182092. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Intelliport System?

BD Intelliport System is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K182092.

When did BD Intelliport System receive FDA 510(k) clearance?

BD Intelliport System received FDA 510(k) clearance on 2019-04-30, under 510(k) number K182092.

Who is the listed applicant for BD Intelliport System?

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 Intelliport System?

The FDA product code for BD Intelliport System is PHC.

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: PHC)

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.

K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)Becton DickinsonK242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc.K230665Dose IQ Safety SoftwareBaxter Healthcare CorporationK223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc.K211124Dose IQ Safety SoftwareBaxter Healthcare Corporation

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.

↑