FDA.report

510(k) K781854

Device
PAD, B-D I.V. CATH.
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K781854
Product code
KGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-04
Date received
1978-11-06
Regulation
878.4200
Classification name
Accessories, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code KGZ  

510(k)DeviceApplicantDecision date
K022306AART SILICONE TUBINGAesthetic and Reconstructive Technologies, Inc.2002-10-10
K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron Medical1998-02-10
K973183WOUND DRAINAGE HOLDERR & D Medical Products, Inc.1998-01-23
K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.1996-01-26
K942315NAVARRE PERCUTANEOUS ACCESS SETNavarre Biomedical , Ltd.1994-07-08
K896087PALESTRANT IRRIGATION AND DRAINAGE SETNorth American Instrument Corp.1989-11-03
K895041OPTICAL CATHETER(TM) INTRODUCER SETSMedical Dynamics, Inc.1989-10-16
K893406DESERET PRN ADAPTERDeseret Medical, Inc.1989-06-22
K873009CONCEPT SWITCHING STICKConcept, Inc.1987-08-17
K870014HCI GENERAL PURPOSE CATHETER STYLETHealth Care Innovations, Inc.1987-02-06
K864115TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SUCathaid, Inc.1986-11-07
K855078ANGIO MED DISPOSABLE PRESSURE CONNECTORSAngiomed U.S., Inc.1986-02-19
K842666NU-THOR THORACOSTOMY KITIntl. Medical Devices , Ltd.1984-09-20
K821525DESERET UNIVERSAL LUER LOCKWarner-Lambert Co.1982-06-23
K821245DESERET OFFSET PRN ADAPTERWarner-Lambert Co.1982-05-13

Legacy Summary

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FDA Review

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