NALU MEDICAL

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3015425075

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
3015425075
FEI Number
3015425075
Entity Name
NALU MEDICAL
City/State/Country
Carlsbad, CA, US
Establishment Address
2320 Faraday Ave., Suite 100, Carlsbad, CA 92008, 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
N
Expiration Date (Year)
2026
510(k) Number
K233801
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
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2026-02-26
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2026-02-26

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
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, US
3022627847 Silk Road Medical Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190960 Boston Scientific Neuromodulation Nalu Lead Blank (50cm) 2019-07-11
K150517 Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator System 2015-06-05
K945103 Medtronic Vascular TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) 1995-01-11

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 3015425075. Last updated year: 2026. Please use registration number 3015425075 when referencing this establishment in official correspondence.
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