FDA.reportPublic FDA data

510(k) K894586

Device
DALE I.V. IDENTIFIER; PRODUCT #1125
Applicant
DALE MEDICAL PRODUCTS, INC.
510(k) number
K894586
Product code
KMK  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-15
Date received
1989-07-24
Regulation
880.5210
Classification name
Device, Intravascular Catheter Securement
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANIEL MCELANEY
Address
7 Cross St. P.O. Box 1556 Plainville MA US 02762 02762

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.2019-07-09
K981860A P HARNESSParaworks Enterprise, Ltd.1999-06-03
K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.1996-10-11
K941098SECURE-SITEOp-Co Medical Products , Ltd.1995-08-09
K943147STATLOCK CVVenetec, Inc.1994-09-29
K943047IV START KITSSterile Concepts, Inc.1994-09-14
K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILETnt Moborg Intl. , Ltd.1994-07-14
K941940IMMOBILE STERILE AND IMMOBILE A/C STERILETnt Moborg Intl. , Ltd.1994-07-14
K935389CONMED VENI-GARD I.V. DRESSINGConmedcorp1994-03-07
K935252K-LOK CATHETER SECUREMENT DEVICE MODIFICATIONK-Lok, Inc.1994-02-18
K940127CENTERMARK SECURING WINGSMenlo Care, Inc.1994-02-09
K932757SECURODRIP (TM) I.V. ARMBOARDOp-Co Medical Products , Ltd.1993-12-08
K925992DUODERM TRANSPARENT HYDROCOLLOID DRESSINGConvatec, A Division of E.R. Squibb & Sons1993-10-15
K930663IV COMFORT PADD.J. Scott Mfg., Inc.1993-09-30
K922103IAB ANCHORDatascope Corp.1993-08-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases