FDA.reportPublic FDA data

Mikro-Tip Catheter Pulse Transducer

Primary DI
00868924000236
Brand
Mikro-Tip Catheter Pulse Transducer
Company
MILLAR INC.
Model
SPT-301
Catalog number
808-1019
Device description
Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K895721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895721000MILLAR MIKRO-TIP PULSE TRANSDUCERMillar Instruments, Inc.1989-12-07DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000236008689240002368689240002360868924000236

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
832-667-7000sales@millar.com

Regulatory Flags#

DUNS number
058269648
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer System850-5148850-51482021-07-16
00868924000205Mikro-Cath Pressure Catheter825-0101825-01012016-10-03
00868924000212Pressure Control Unit PCU-2000PCU-2000880-01292016-09-30
00868924000229TC-510 Pressure Control UnitTC-510851-59182016-09-30

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