FDA.reportPublic FDA data

510(k) K933020

Device
Mod. Phantom 5 Plus Urol. Balloon Dilation Catheter
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K933020
Product code
EYB
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-03
Date received
1993-06-22
Regulation
876.5130
Classification name
Catheter, Ureteral, Gastro-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LORRAINE HANLEY
Address
2710 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EYB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192183RocaTub Ureteral CatheterPromepal Sam2020-04-23
K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.2019-09-18
K183323UPJ Occlusion Balloon CatheterCook Incorporated2019-08-05
K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated2019-06-17
K182122Ureteric CathetersColoplast Corp.2018-10-04
K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated2018-09-14
K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp.2017-12-21
K133750OCCLUDER OCCLUSION BALLOON CATHETERBoston Scientific Corporation2014-01-08
K092250MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.2010-01-21
K083788ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSREndooptiks, Inc.2009-03-03
K043581DUAL LUMEN CATHETERAcmi Corporation2005-03-03
K030293AMSURE RED RUBBER URETHRAL CATHETERAmsino International, Inc.2004-02-04
K033368FOSSA URETERAL OPEN LUMEN STENTFossa Medical, Inc.2003-11-26
K032521BARD DUAL LUMEN URETERAL CATHETERC.R. Bard, Inc.2003-11-14
K021856PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XXPorges S.A.2002-10-17