Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021767551

FEI Number

3021767551

Entity Name

ALLEVA MEDICAL DEVICES

City/State/Country

Brea, CA, US

Establishment Address

1050 W. Central Avenue, Unit B, Brea, CA 92821, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Alleva Medical Devices (Owner Number: 10084505)

Owner / Operator Contact Address

1050 W. Central Avenue, Unit B, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trocar thoracic catheters extriCARE 3600, canister and Foam Kits (EC3600-100C-E, EC-FOAM-S-E, EC-FOAM-M-E, EC-FOAM-L-E, EC-DOME, EC-DRAPE) F1 Chest Tubes ExtrICARE 3000 Negative Pressure Wound Therapy System 100cc Canister (EC3000-100C) extriCARE 3000 Negative Pressure Wound Therapy System (EC3000) ExtriCARE 3000 Negative Pressure Wound Therapy System 400cc Canister (EC3000-400CC) Yarrow Woundbrush extriCARE 3600 Negative Pressure Wound Therapy System 1000cc Collection Canister (EC3600-1000C-E) Thoracic Catheter - Firm and Thermosensitive PVC, Silicone extriCARE 2400 Negative Pressure Wound Therapy System - 250cc and 400cc collection canister (EC2400-400C-E) 1000mL "Bag" Suction Liner with solidifier (MI285-0015) Vide Wave Three-Chamber Water Seal Chest Drain (ST380-0001) 1800mL Suction Canister (MI130) Transition tube with Luer Connector (ST380-0600) Vide Shore Dry Suction / Water Seal Chest Drain (ST381-0001) 8-12Fr Step-down connector (ST380-0100) Vide Breeze Chest Drain Valve (ST425-0001) 1500mL Rigid Suction Canister (MI202-0004) Vide Sand Dry Seal Chest Drain (ST382-0001) 1800mL Suction Liner (MI158) 2000mL "Bag" Suction Liner (MI287-0008) Vide Transition Tube with Luer Connector (ST380-0600) Rigid High Flow Suction Canister (MI277) Rigid High Flow Suction Canister (MI278) Chest Drain Basket with Clamp (HC063-0002) 3200mL Suction Liner (MI159) Vide Wave Pediatric Water Seal Chest Drain (ST422-0001) Y-Tubing Set for Dual Catheter Connection (ST380-0400) 1000mL Suction Canister (MI129-0013) 2000mL "Bag" Suction Liner with solidifier (MI287-0015) 800mL Rigid Suction Canister (MI055-0012) 3000mL "Bag" Suction Liner (MI288-0008) 1500mL "Bag" Suction Liner with solidifier (MI286-0015) Vide Wave Three-Chamber Water Seal Chest Drain, with inline sampling port connector (ST380-0006) Vide Manual Suction Bulb, Non-Sterile (ST380-0700) 1200mL Rigid Suction Canister (MI056-0012) 1500mL Suction Canister (MI358-0013) Chest Drain Basket with Hanger and Clamp (HC063-0001) 1000mL "Bag" Suction Liner (MI285-0008) Vide Shore Dual Chamber Dry Suction Water Seal Drain (ST423-0001) 1300mL Suction Canister (MI129) 3000mL "Bag" Suction Liner with solidifier (MI288-0015) 2000mL Suction Canister (MI301-0013) 3000mL Suction Canister (MI302-0013) Patient stepped connector (for 16-40Fr catheter) (ST380-0300) 1500mL "Bag" Suction Liner (MI286-0008) Vide Shore Pediatric Dry Suction Water Seal Chest Drain (ST424-0001) 3200mL Suction Canister (MI131) 1500mL Suction Lid Liner (MI243) 3000mL Suction Lid Liner (MI248) Y-Tubing Set for Suction-Dual Drain Connection (ST380-0500) Vide Sterile End Cap for In-Line Connector (ST380-0900) 1300mL Suction Liner (MI157) 1000mL Suction Lid Liner (MI217) In-line Needleless Sampling Port Connector (ST380-0200)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-12-02
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-02-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-03-14
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-03-01
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-12-02
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2024-05-01
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-02-10
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-05-09
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2026-02-22
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-05-09
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-03-01
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2024-02-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2022-10-30
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2022-10-30

Official Correspondent

Max Choi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alleva Medical Devices

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021767551. Last updated year: 2026. Please use registration number 3021767551 when referencing this establishment in official correspondence.