Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020735

FEI Number

2020735

Entity Name

AXIOM MEDICAL, INC.

City/State/Country

TORRANCE, CA, US

Establishment Address

19320 SOUTH VAN NESS AVE., TORRANCE, CA 90501, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AXIOM MEDICAL, INC. (Owner Number: 2020735)

Owner / Operator Contact Address

19320 SOUTH VAN NESS AVE., --, Torrance, CA 90501, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K883887

PMA Number

N/A

All Registered Proprietary Names

Multipurpose Wound Drain Axiom(R) Axiom(R) Multipurpose Wound Drain Atraum(TM) Axiom(R) Thoracic PVC Catheter Axiom(R) Trocar Thoracic Catheter Axiom(R) Axiom® NS Continuous Tubing Axiom® Medical Inc Axiom(R) CW Sump Axiom(R) CWV Drainage System Axiom(R) CWV Drain Axiom(R) 3M Closed Wound Vacuum Drainage System Axiom(R) Axiom(R) Axiom(R) Femoral Venous Catheter Axiom(R) Tubing Axiom(R) Silicone Penrose Atraum(TM) Interpleural Anesthesia Catheter Axiom(R) CWV Drain with Trocar Petite(R) Wound Drain Axiom(R) Atraum(TM) ClotStop(R) Facial Drain with Trocar SeroVac(R) Axiom(R) Abdominal Uni-Sump Axiom(R) Hacienda Sump(R) Axiom(R) Filtered Mediastinal Sump Axiom(R) Axiom(R) Suture Rings Axiom(R) Sump n' Sheath(R) Axiom(R) Mills Filtered Mediastinal Sump Axiom(R) Abdominal Filtered Dual-Sump Axiom(R) Abdominal Dual-Sump Lig-a-Loops(TM) Axiom(R) Lig-a-Loops(TM) Axiom(R) Axiom(R) Atraum(TM) Abdominal Uni-Sump Axiom(R) Atraum(TM) Mills Filtered Mediastinal Sump Axiom(R) Atraum(TM) CWV with Trocar Axiom(R) Atraum(TM) Facial Drain Axiom(R) Atraum(TM) Petite(R) Wound Drain Axiom(R) Atraum(TM) CW Sump Axiom(R) Atraum(TM) CWV Drainage System Atraum(TM) Axiom(R) Atraum(TM) Saphenous Vein Drain Axiom(R) Atraum(TM) Abdominal Dual-Sump Axiom(R) Atraum(TM) Petite(R) Wound Drainage System Axiom(R) Atraum(TM) Hacienda Sump(R) Axiom(R) Atraum(TM) Wound Drains Axiom(R) Axiom(R) Atraum(TM) Abdominal Filtered Dual-Sump Axim(R) Atraum(TM) Mediastinal Silicone Drain Axiom(R) Atraum(TM) Petite(R) Wound Drainage Kit Axiom(R) Atraum(TM) Sump n' Sheath(R) Axiom(R) Atraum(TM) Thoracic Silicone Drain Axiom(R) Atraum(TM) CWV Drain Axiom(R) Atraum(TM) Filtered Mediastinal Sump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2010-12-23
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2016-09-11
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2010-12-23
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2019-06-24
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2010-12-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-12-23
KDH	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration	Gastroenterology, Urology	Class 2	876.5980	2011-12-28
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2010-12-23
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2016-09-11
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2010-12-23
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-12-23
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2010-12-23

Official Correspondent

J. RAE WALKER, M.D.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AXIOM MEDICAL, INC.

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
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020735. Last updated year: 2026. Please use registration number 2020735 when referencing this establishment in official correspondence.