FDA.reportPublic FDA data

Mikro-Cath Pressure Catheter

Primary DI
00868924000205
Brand
Mikro-Cath Pressure Catheter
Company
MILLAR INC.
Model
825-0101
Catalog number
825-0101
Device description
The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
K093111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093111000MIKRO-CATH, MODEL 825-0101Millar Instruments, Inc.2010-01-05DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000205008689240002058689240002050868924000205

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

Contacts#

Phone, Email table
PhoneEmail
832-667-7131jjean-baptiste@millar.com

Regulatory Flags#

DUNS number
058269648
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00868924000212Pressure Control Unit PCU-2000PCU-2000880-01292016-09-30
00868924000229TC-510 Pressure Control UnitTC-510851-59182016-09-30
00868924000236Mikro-Tip Catheter Pulse TransducerSPT-301808-10192016-10-21

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Primary DI, Brand, Company table
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