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510(k) K895041

Device
OPTICAL CATHETER(TM) INTRODUCER SETS
Applicant
MEDICAL DYNAMICS, INC.
510(k) number
K895041
Product code
KGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-16
Date received
1989-08-09
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

Applicant Contact#

Contact
JO BREHM
Address
99 Inverness Dr. E. Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGZ  #

510(k), Device, Applicant table
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
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
K810530PERI-PATCH GLUE MOLDQuinton, Inc.1981-03-24

Legacy Summary#

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FDA Review#

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