Atlas FDA

MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER

FDA 510(k) clearance K931619 · decided 1993-08-20

Clearance details

K-number
K931619
Device name
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1993-04-02
Decision date
1993-08-20
Days to decision
140 days
Clearance type
Traditional
Product code
GCA
Device class
2
Regulation number
876.5010
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
San Jose, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Stone Retrieval Balloon Catheter (K253013)Zhejiang Soudon Medical Technology Co., Ltd.2026-05-08
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SpyGlass Discover Balloon Dilation Catheter (K212582)Boston Scientific Corporation2022-05-06
Stone Retrieval Balloon Catheter (K210660)Anrei Medical (Hangzhou) Co., Ltd.2021-04-27
Stone Retrieval Balloon (K200173)Hangzhou AGS MedTech Co., Ltd.2020-05-01
Fusion Quattro Extraction Balloon (K200247)Wilson-Cook Medical, Inc.2020-02-27
Tri-Ex Extraction Balloon with Multiple Sizing (K193344)Wilson-Cook Medical, Inc.2019-12-13
Howell D.A.S.H Extraction Balloon with Multiple Sizing (K173659)Wilson-Cook Medical, Inc.2018-07-06
Advance Biliary Balloon Catheter (K173414)Cook Incorporated2018-06-22
Tri-Ex Extraction Balloon With Multiple Sizing (K170292)Wilson-Cook Medical, Inc.2017-09-20
FUSION QUATTRO EXTRACTION BALLOON XL (K063677)Wilson-Cook Medical, Inc.2007-01-05
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (K040129)Wilson-Cook Medical, Inc.2004-02-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Vercise Deep Brain Stimulation (DBS) Systems (P150031/S096)Boston Scientific Corp2026-07-16
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S397)Boston Scientific Corp2026-07-10
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S095)Boston Scientific Corp2026-07-10