510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931619Substantially Equivalent

Microvasive Extractor, Retrieval Balloon Catheter

Boston Scientific Corporation, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931619 is the FDA 510(k) clearance record for MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER, a class II device, cleared for Boston Scientific Corp on under FDA product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K931619.

Clearance record

Decision date
Received
(140 days to decision)
Product code
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code GCA

Trailing 12 months
1 clearance under product code GCA in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GCA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260