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510(k) K050232

Device
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K050232
Product code
PID  
Decision
Substantially Equivalent (SESE)
Decision date
2005-03-11
Date received
2005-02-01
Regulation
876.5980
Classification name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAIGE SWEENEY
Address
One Boston Scientific Pl. Natick, MA US 01760 01760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc.2019-01-25
K132337ESOFLIP BALLOON DILATION CATHETERCrospon, Ltd.2013-10-07

Legacy Summary#

summary

FDA Review#

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