BOSTON SCIENTIFIC CORPORATION

FDA Device Registration & Listing · Johns Creek, GA, US · Registration 3032507796

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032507796
FEI Number
3032507796
Entity Name
BOSTON SCIENTIFIC CORPORATION
City/State/Country
Johns Creek, GA, US
Establishment Address
11480 Lakefield Drive, Johns Creek, GA 30097, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2016-12-22
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2016-12-22
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2018-09-21
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2008-01-15
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2025-12-31
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2022-04-13
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-12-22
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2016-12-23
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2016-12-23
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2018-12-07
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2001-10-11

Official Correspondent

Adrienne Bishop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Scientific Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025434462 Obsidio Inc Maple Grove, MN, US
3005619880 Boston Scientific Corporation Roswell, GA, US
3015425075 NALU MEDICAL Carlsbad, CA, US
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032507796. Last updated year: 2026. Please use registration number 3032507796 when referencing this establishment in official correspondence.
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