FDA.reportPublic FDA data

510(k) K926039

Device
Guide-tech Encapsulated Guidewire
Applicant
CAPE TECH MEDICAL PRODUCTS
510(k) number
K926039
Product code
KNY
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-05
Date received
1992-12-01
Regulation
876.5130
Classification name
Accessories, Catheter, G-U
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
AL BICCUM
Address
23 Davedon Dr. Falmouth MA US 02536 02536

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.2026-08-05
K182144Bi-Flex EvoPromepla Sam2018-09-07
K162356Vesair Cystoscopic SheathSolace Therapeutics2017-03-02
K140441BI-FLEX URETERAL ACCESS SHEATHPromepla Sam2014-06-17
K140562WIJAY EZ-VOID EXTERNAL CATHETER VALVELeomed, LLC2014-06-16
K141252GUARDIAN URETHRAL SHEATHSolace Therapeutics2014-06-09
K131803GUARDIAN URETHRAL SHEATHSolace Therapeutics2013-08-20
K123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies America2013-02-04
K120160ROCAMED ROCAUS PLATINUMPromepla Sam2012-05-14
K112209PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2011-09-08
K090121PRE-FILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2009-04-15
K052298CYSTOGLIDE INTRODUCER SHEATHPercutaneous Systems, Incorporated2006-12-12
K062240CAREVENTChief Medical, LLC2006-10-16
K052952CATHASSISTPhysician Technologies, Inc.2006-05-14
K052134CYSTOGLIDE DILATING INTRODUCER SHEATHPercutaneous Systems, Inc.2005-09-22