FDA.reportPublic FDA data

ACIST Navvus®II Catheter

Primary DI
10841716102483
Brand
ACIST Navvus®II Catheter
Company
ACIST MEDICAL SYSTEMS, INC.
Model
016675
Device description
Navvus II Catheter, p/n 701711-002
Published
2020-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OBICatheter, Pressure Monitoring, Cardiac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBICatheter, Pressure Monitoring, CardiacCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190473000ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.2019-09-13OBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841716102480PackageGS15In Commercial Distribution
30841716102487PackageGS11In Commercial Distribution
10841716102483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084171610248020841716102480
3084171610248730841716102487
1084171610248310841716102483

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip transducer, pressureA device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
926684994
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841716102704ACIST VeraPro HiFi 1650188042026-05-26
10841716102728ACIST VeraPro FLX 1650188062026-05-26
10841716102742ACIST VeraPro S100 Multi-Use Syringe0188082026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity Syringe0188112026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and Transducer0188142026-05-26
10841716103992ACIST HDi™ Cart0179912026-03-04
10841716103442CT Exprès Bottle Spike A6404582025-12-09
10841716103466CT Exprès Day Set III HP6404602025-12-09
10841716101561BT2000 Automated Manifold Kit0146132020-11-06
10841716101943A2000 Multi-use Syringe Kit0146122018-06-06
10841716101974BT2000 Automated Manifold Kit0146132018-06-06
10841716101998AngioTouch® Kit0146442018-06-06
10841716102001AngioTouch® Kit0146452018-06-06
10841716102155A1000 Single Use Syringe Kit0166062019-10-09
10841716102162Single-use Syringe Kit0166052019-10-16
10841716102520A1000V Single Use Syringe Kit0166052024-05-28
10841716102544A2000 Multi-use Syringe Kit0146122020-11-06
10841716102605A1000 Single Use Syringe Kit0166062020-11-06
10841716102612Single-use Syringe Kit0166052020-11-06
10841716101875ACIST CVi® Contrast Delivery System Injector Head0162242018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103244ACIST Navvus®II CatheterACIST MEDICAL SYSTEMS, INC.OBI2025-01-20
30841716102845RXi® Console CableACIST MEDICAL SYSTEMS, INC.OBI2021-06-17
30841716102692RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2020-05-12
30841716102180RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2019-01-16
30841716102067RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-09-26
30841716102074RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-09-26
10841716101738ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
30841716101732ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
40841716101746ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
30841716102012RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-02-20
30841716100360RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716100377RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101701RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101718RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101725RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
40841716100732ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2017-02-17
10841716101448ACIST RXi® Ao Interface BoxACIST MEDICAL SYSTEMS, INC.OBI2016-12-08
40841716100664ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2016-10-13
10841716100588ACIST RXi® Bed Rail MountACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
10841716100595ACIST RXi® CartACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
10841716101257ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100384ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100391RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100407RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100414RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100421RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100438RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100445RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100452RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100469RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09