Data / Medical devices / Costa Rica / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Cartago, Costa Rica, 10 510(k) clearances

Name: Boston Scientific Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corporation is registered with the FDA (registration 3025341484) in Cartago, Costa Rica. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Boston Scientific Corporation

FDA registration number: 3025341484
Address: Zona Franca La Lima, Cartago, Costa Rica, 30106
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer
First device listed: September 1, 2021
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Septostomy	DXF	2	Manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 27, 2025	K250310	VIKING Fixed Curve Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 1, 2024	K242076	VersaCross RF Wire	DXF	Substantially Equivalent	Baylis Medical Company	accessdata.fda.gov
February 1, 2024	K240018	WATCHMAN TruSteer Access System (M635TU90050)	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 14, 2023	K233647	VersaCross Connect Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 9, 2022	K220414	VersaCross Connect Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
August 13, 2021	K212228	WATCHMAN FXD Curve Access System	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 12, 2020	K201288	ExpanSure Large Access Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 20, 2019	K183655	VersaCross Transseptal Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
June 17, 2015	K150709	ProTrack RF Anchor Wire	DXF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 28, 2008	K073326	NRG TRANSSEPTAL NEEDLE	DXF	Substantially Equivalent	Baylis Medical Co., Inc.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.