510(k) K932228

MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER by Boston Scientific Corp — Product Code GBZ

K932228 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
May 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type