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Boston Scientific Corporation: FDA-registered device maker in Waltham, MA, United States, 6 510(k) clearances and 2 PMA approvals

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 3010705768) in Waltham, MA, United States. It lists 7 device types. The FDA files 6 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 29, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010705768
Address: 309 Waverley Oaks Rd., Waltham, MA, United States, 02452
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Specification developer
First device listed: August 27, 1992
Registered through: 2026
Brand names listed: Blazer II XP Temperature Ablation Catheter, Blazer Open-Irrigated Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, Blazer Solid-Tip Ablation Cather Cable, Sterile Cable, Cable IntellaTip MiFi OI to Maestro 4000, Cable IntellaTip MiFi XP Sterile Cable, Cable, IntellaNav Ablation Catheter, Cable, IntellaTip MiFi OI and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Specification developer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Specification developer	accessdata.fda.gov
Cardiac Ablation Percutaneous Catheter	LPB	3	Specification developer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Specification developer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Specification developer	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
August 29, 2024	K241227	RHYTHMIA HDx Mapping System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 10, 2022	K220796	IntellaMap Orion High Resolution Mapping Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 27, 2019	K192438	Rhythmia HDxTM Mapping System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 25, 2018	K173837	RHYTHMIA HDx Mapping System (with software Version 2.0)	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 10, 2017	K162793	RHYTHMIA HDx Mapping System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 22, 2013	K130750	RHYTHMIA MAPPING SYSTEM	DQK	Substantially Equivalent	Rhythmia Medical, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 24, 2016	P150005	BLAZER OPEN-IRRIGATED ABLATION CATHETER	OAD	91	December 5, 2025	accessdata.fda.gov
August 25, 2003	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	141	October 17, 2025	accessdata.fda.gov

Compare with other makers

Updated December 5, 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.