FDA.reportPublic FDA data

ACIST Navvus® Catheter

Primary DI
10841716101240
Brand
ACIST Navvus® Catheter
Company
ACIST MEDICAL SYSTEMS, INC.
Model
014667
Device description
Navvus Catheter, p/n 701481-010
Published
2017-08-15
Public version status
Update
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
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132474000CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETERAcist Medical Systems2014-01-30DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841716101247PackageGS15In Commercial Distribution
30841716101244PackageGS11In Commercial Distribution
30841716102340PackageGS15In Commercial Distribution
10841716101240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084171610124720841716101247
3084171610124430841716101244
3084171610234030841716102340
1084171610124010841716101240

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
07460691952775TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
07460691955882TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
00690103210828Combo KitsEdwards Lifesciences LLCDXO2025-07-15
07460691925298TRUWAVE/VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691925731TRUWAVE X 2 (3 CC) /VAMP 98 IN (250 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691926769TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691930179TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691948990TRUWAVE X 2 (3 CC) /VAMP 86 IN (220 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949003TRUWAVE (3 CC) /VAMP 88 IN (225 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949553TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691956094TRUWAVE (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691924840TRUWAVE X 3 (3 CC) /VAMP 75 IN (190 CM)Edwards Lifesciences LLCDXO2024-09-04
07460691924956TRUWAVE, VAMP JREdwards Lifesciences LLCDXO2024-09-04
07460691947221TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947245TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947467TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691949287TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-04
00852004007208Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007222Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007031Endophys Pressure Sensing Sheath Kit - 8F 11 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007062Endophys Pressure Sensing Sheath Kit - 6F 12 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007079Endophys Pressure Sensing Sheath Kit - 8F 25 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
10888277804128Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXO2023-07-29
00690103216806TruWaveEdwards Lifesciences LLCDXO2022-08-18
10888277655379MedlineMEDLINE INDUSTRIES, INC.DXO2020-12-25
07460691952829TRUWAVE X 3 (3 CC)Edwards Lifesciences LLCDXO2020-11-12
07460691949270TRUWAVE, VAMPEdwards Lifesciences LLCDXO2020-11-10
00690103199406TRUWAVE, VAMP JR.Edwards Lifesciences LLCDXO2020-08-26
00690103210453Combo KitsEdwards Lifesciences LLCDXO2020-05-12
00690103197129TRUWAVE, VAMP PLUSEdwards Lifesciences LLCDXO2020-04-24