BRAINSPACE Inc

FDA Device Registration & Listing · Bothell, WA, US · Registration 3043513133

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
3043513133
FEI Number
3043513133
Entity Name
BRAINSPACE Inc
City/State/Country
Bothell, WA, US
Establishment Address
22121 17th Ave Se Ste 112, Bothell, WA 98021, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BrainSpace (Owner Number: 10095057)
Owner / Operator Contact Address
22121 17th Ave SE, Suite 112, Bothell, WA 98021, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Intellidrop

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2026-01-19
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2026-01-19

Official Correspondent

Caitlin Morse

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21

Similar Registrations

Registration Number Establishment Name Location
3015531529 Medtronic Neurosurgery Fort Worth, TX, US
3004593495 Plexus Manufacturing Sdn. Bhd. Bayan Lepas Pulau Pinang, MY
3014334038 Integra LifeSciences Production Corporation Mansfield, MA, US
3012507533 Integra Canada ULC Oakville Ontario, CA
3003418325 Integra LifeSciences Corporation Princeton, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043513133. Last updated year: 2026. Please use registration number 3043513133 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.