FDA.reportPublic FDA data

Primi™ Support Catheter

Primary DI
M781P1420150HF1
Brand
Primi™ Support Catheter
Company
Thermopeutix, Inc.
Model
P14-20-150HF
Device description
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Published
2016-09-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130850000PRIMI AND SECONDI SUPPORT CATHETERSThermopeutix, Inc.2013-06-25DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M781P1420150HF1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-858-549-1760customer.service@thermopeutix.
1-858-549-1760customer.service@thermopeutix.com

Regulatory Flags#

DUNS number
138648154
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M78110010101TAPAS® Catheter100-10102016-09-19
M78110045251TAPAS® Catheter100-45252016-09-19
M78110060601TAPAS® Catheter100-60602016-09-19
M78110080801TAPAS® Catheter100-80802016-09-19
M78110445451TAPAS® Catheter 104-45452016-09-15
M78110460601TAPAS® Catheter 104-60602016-09-15
M78110480801TAPAS® Catheter 104-80802016-09-15
M7819110451TAPAS® Catheter91-10452016-09-19
M7819110601TAPAS® Catheter91-10602016-09-19
M7819110801TAPAS® Catheter91-10802016-09-19
M7819145251TAPAS® Catheter91-45252016-09-19
M7819145451TAPAS® Catheter91-45452016-09-19
M7819160251TAPAS® Catheter91-60252016-09-19
M7819160451TAPAS® Catheter91-60452016-09-19
M7819160601TAPAS® Catheter91-60602016-09-19
M7819180251TAPAS® Catheter91-80252016-09-19
M7819180451TAPAS® Catheter91-80452016-09-19
M7819180601TAPAS® Catheter91-80602016-09-19
M7819180801TAPAS® Catheter91-80802016-09-19
M7819210101TAPAS® Catheter92-10102016-09-19

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Primary DI, Brand, Company table
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