FDA.reportPublic FDA data

510(k) K983373

Device
IMPACT BALLOON DILATION CATHETER
Applicant
B. BRAUN/MCGAW
510(k) number
K983373
Product code
KNQ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-22
Date received
1998-09-24
Regulation
876.5365
Classification name
Dilator, Esophageal
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
MARK S ALSBERGE
Address
824 12th Ave. Bethlehem PA US 18018 18018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific Corp2012-10-24
K093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.2009-11-10
K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook Endoscopy2009-09-25
K082995SMART DILATORSafestitch Medical2009-02-06
K061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook Endoscopy2006-12-01
K061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific Corp2006-09-21
K060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDCordis Europa, N.V.2006-04-11
K043605INSCOPE 3-STAGE BALLOON DILATORCordis Europa, N.V.2005-02-04
K033936BARD ELIMINATOR PET BALLOON DILATORSC.R. Bard, Inc.2004-01-14
K031147OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOREthicon Endo-Surgery, Inc.2004-01-12
K023907CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETERCordis Corp.2002-12-18
K002363MEDOVATIONS ESOPHAGEAL DILATORMedovations, Inc.2000-11-01
K993720CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETERCordis Corp.2000-01-18
K990935JACKSON ESOPHAGEAL DILATORPilling Weck Surgical1999-05-17
K974788CRE(TM) BALLOON DILATATION CATHETERBoston Scientific Corp1998-03-20

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