Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649139

FEI Number

3002406063

Entity Name

KDL MEDICAL, INC.

City/State/Country

RICHARDSON, TX, US

Establishment Address

800 E Campbell Rd Ste 252, RICHARDSON, TX 75081, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

KDL MEDICAL, INC. dba CHASE MEDICAL (Owner Number: 9028011)

Owner / Operator Contact Address

800 E. Campbell Rd., Suite 252, Richardson, TX 75081, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blower Mister TRIPOD Heart Stabilizer Nylon Blower/Occluder TRIPOD Heart Stabilizer Nylon with Blower TRIPOD Heart Stabilizer Med Metal with Blower Vessel Shunt, 2mm Tip,12mm Shaft Vessel Shunt, 1.75mm Tip,12mm Shaft Vessel Shunt, 1.25mm Tip,12mm Shaft Vessel Shunt, 4mm Plug,12mm Shaft Vessel Shunt, 2.5mm Tip,12mm Shaft Vessel Shunt, 1.5mm Tip,12mm Shaft Vessel Shunt, 10mm Tip,12mm Shaft Vessel Shunt, 2.5mm Plug, 30mm Shaft Vessel Shunt, 4mm Plug, 30mm Shaft Vessel Shunt, 2mm Plug, 30mm Shaft Vessel Shunt, 3mm Plug, 30mm Shaft Vessel Shunt, 3mm Plug,12mm Shaft Vessel Shunt, 2.25mm Tip, 12mm Shaft TRIPOD Heart Stabilizer Lt Metal FASTRACT VIPER Tubing Set TRIPOD Heart Stabilizer Nylon FASTRACT TRIPOD Heart Stabilizer Lt Metal w/Occluder TRIPOD Heart Stabilizer Nylon Occ FASTRACT VIPER II Apical Lift TRIPOD Heart Stabilizer Nylon FASTRACT +2cm TRIPOD Heart Stabilizer Nylon Texture VIPER II Heart Stabilizer FASTRACT Sternal Retractor TRIPOD Heart Stabilizer Medium Metal TRIPOD Heart Stabilizer Lt Mtl FASTRACT +4cm FASTRACT Suture Stay - Single TRIPOD Heart Stabilizer Med Metal FASTRACT TRIPOD Heart Stabilizer Lt Mtl FASTRACT +2cm VIPER Heart Stabilizer VIPER Heart Stabilizer, Universal Mount TRIPOD Heart Stabilizer Nylon w/Occluder FASTRACT Suture Stay - Double Disposable Platform Blades

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2008-03-19
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-19
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1997-03-06

Official Correspondent

JACKIE LAFOLLETTE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KDL MEDICAL, INC. dba CHASE MEDICAL

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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
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.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649139. Last updated year: 2026. Please use registration number 1649139 when referencing this establishment in official correspondence.