Breethe, Inc.

FDA Device Registration & Listing · Halethorpe, MD, US · Registration 3014990448

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
3014990448
FEI Number
3014990448
Entity Name
Breethe, Inc.
City/State/Country
Halethorpe, MD, US
Establishment Address
1500 Joh Ave, #190, Halethorpe, MD 21227, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ABIOMED, INC. (Owner Number: 1220648)
Owner / Operator Contact Address
22 CHERRY HILL DR., --, Danvers, MA 01923, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223161
PMA Number
N/A

All Registered Proprietary Names

OXY-1 System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2023-04-20
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2023-04-20
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2023-04-20
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2023-04-20

Official Correspondent

Anshul Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
1220648 ABIOMED, INC. DANVERS, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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3012119238 KYOCERA Medical Corporation Shiga Yasu Plant Yasu-shi Shiga, JP
3015431638 APMTD, INC. Wilmington, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014990448. Last updated year: 2026. Please use registration number 3014990448 when referencing this establishment in official correspondence.
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