Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1625519

FEI Number

1625519

Entity Name

NOVOSCI CORP.

City/State/Country

Conroe, TX, US

Establishment Address

2021 Airport Road, Conroe, TX 77301, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

NOVOSCI CORP. (Owner Number: 9057741)

Owner / Operator Contact Address

2021 Airport Road, --, Conroe, TX 77301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K801402

PMA Number

N/A

All Registered Proprietary Names

CARDIOPULMONARY BYPASS CARDIOTOMY RETURN SUCKER CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING CARDIOPULMONARY BYPASS ARTERIAL LINE BLOOD FILTER CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK AND MANIFOLD FITTING CARDIOPULMONARY BYPASS ACCESSORY EQUIPMENT CARDIOVASCULAR SURGICAL INSTRUMENTS CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK AND MANIFOLD FITTING CARDIOPULMONARY BYPASS ACCESSORY EQUIPMENT CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES CARDIOPULMONARY BYPASS BLOOD RESERVOIR CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK AND MANIFOLD FITTING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2000-01-27
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-12-02
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2000-01-27
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-12-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-12-02
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2000-01-27
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2000-01-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2000-01-27
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2011-12-02
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2011-12-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-12-02
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2011-11-29
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2011-12-02
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2011-12-02
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2011-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NOVOSCI CORP.

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
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K914791	Gish Biomedical, Inc.	GISH ARTERIAL FILTER	1993-04-06
K790435	Surgikos, Inc.	*INTERSEPT BLOOD FILTER W/ TUBING BYPASS**	1979-03-27
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

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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3005213560	HMT Medizintechnik GmbH	Maisach Bavaria, DE
2011171	Sterigenics US LLC	Los Angeles, CA, US
9680619	SMT SCHILLING METALLTECHNIK GMBH	MUHLHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1625519. Last updated year: 2026. Please use registration number 1625519 when referencing this establishment in official correspondence.