FDA.reportPublic FDA data

PressureWire™

Primary DI
05414734055796
Brand
PressureWire™
Company
ST. JUDE MEDICAL, INC.
Model
C12308
Catalog number
C12308
Device description
Guidewire Mounted Sensor
Published
2015-12-09
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
DQXWIRE, GUIDE, CATHETER
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140466000PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300St. Jude Medical Systems AB2014-11-13DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734055793PackageGS15In Commercial Distribution
05414734055796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405579315414734055793
05414734055796054147340557965414734055796

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

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