Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031571797

FEI Number

3031571797

Entity Name

ENABLECV, LLC

City/State/Country

Midvale, UT, US

Establishment Address

6967 S River Gate Dr. Ste 104, Midvale, UT 84047, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

enableCV, LLC (Owner Number: 10092279)

Owner / Operator Contact Address

6967 S River Gate Dr. Ste 104, Midvale, UT 84047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131627

PMA Number

N/A

All Registered Proprietary Names

Thruport Endovent Pulmonary Catheters Carotid shunts Thruport Endoclamp Aortic Catheters Thruport Endodirect Arterial Cannula Axillary Access Arterial Cannulae Femoral Access Arterial; Venous Cannulae (FEMS) Embol-X Arterial Filter EMBOL-X ARTERIAL FILTER Cardioplegia Delivery Sets Left Atrial Pressure Monitoring Catheter ProPlege Peripheral Retrograde Cardioplegia Device EndoReturn Arterial Cannulae Vent Catheters Thruport Endoclamp Aortic Catheters Vascushunt carotid shunts VisuFlo Blower Port Access EV cardiopulmonary bypass system INTRODUCER SHEATH KIT, 9 FR Arterial Cannula Families (EZ Glide, OptiSite and EndoReturn) OptiSite Arterial Cannula Percutaneous Insertion Kit (PIKA5 - Arterial, PIKV5 - Venous) Retrograde Cardioplegia Catheters QuickDraw Plus Venous Cannula (QDP25) Aortic Perfusion Cannulae; Pediatric Peripheral access arterial cannula FAPCath Femoral arterial pressure monitoring catheter Porous Vent plugs FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA FemTrak Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula; Fem-Flex II Femoral Venous Cannula; Femoral Venous Cannula EMBOL-X Introducer Sheath; EXIS Anastaflo Intravascular Shunts Thruport Endoplege Coronary Sinus Catheter Cardioplegia Kits Intraclude Intra-Aortic Occlusion Device Janke-Barron Heart Support Embol-X arterial cannulae Duraflo-Treated Suction Wands Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Aortic Perfusion Cannulae - EZ Glide Thruport Endoclamp Aortic Catheters Single Stage Venous Drainage Cannula INTRODUCER SHEATH KIT,11 FR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-15
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2026-03-31
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2026-03-31
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2026-03-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-01-08
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-03-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-03-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-15
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2026-01-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-01-15
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2026-06-01
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-03-31
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4430	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-30
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-03-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-30
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-03-31

Official Correspondent

Hannah Putnam

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

enableCV, LLC

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-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031571797. Last updated year: 2026. Please use registration number 3031571797 when referencing this establishment in official correspondence.