TAPAS® Catheter

Primary DI
M7819260601
Brand
TAPAS® Catheter
Company
Thermopeutix, Inc.
Model
92-6060
Device description
The TAPAS® Catheter consists of a two concentric tubular shafts (proximal occlusion balloon and distal occlusion balloon, POB and DOB, respectively) and is used to infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The proximal infusion lumen (Red) may be accessed using external devices connected to this lumen. There are three additional smaller lumens: one lumen is used for inflation of the balloon on the DOB; one lumen is used for inflation of the balloon on the POB; and one lumen permits pressure monitoring (Yellow) distal to the proximal occlusion balloon. The simultaneous inflation of the balloons may isolate a target region within a vessel and allow the infusion of a fluid agent into the vascular region of interest. The catheter is supplied with hydrophilic coating.
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112219000TAPAS CATHETERThermopeutix, Inc.2011-11-18MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7819260601PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. 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
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.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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