FDA.reportPublic FDA data

PressureWire™

Primary DI
05415067025722
Brand
PressureWire™
Company
LIGHTLAB IMAGING, INC.
Model
C12359
Catalog number
C12359
Device description
X Guidewire
Published
2016-08-19
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
DQXWIRE, GUIDE, CATHETER
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161171000PressureWire X GuidewireSt. Jude Medical, Inc.2016-08-15DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067025729PackageGS15In Commercial Distribution
05415067025722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506702572915415067025729
05415067025722054150670257225415067025722

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
Outer Diameter0.014Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Keep dry, Keep away from sunlight, Excusrsions permitted -20C-50C, 25%-90% humidity
Special Storage Condition, Specify00Store at room temperature in a dry and dark place. Do not use if package is damaged.
Storage Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
018493531
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054920Ultreon™ULTR300001ULTR3000012026-05-19
05415067053879ILUMIEN™ OPTIS™ to OPTIS™UIMG901003UIMG9010032025-07-31
05415067047694Ultreon™101531010153102024-03-29
05415067025715PressureWire™C12059C120592016-08-19
05415067025739PressureWire™C12009C120092016-08-19
05415067048882AptiVue™101520910152092023-09-29
00183739000647Dragonfly™ OPTIS™C408645C4086452015-04-20
00183739000654Dragonfly™ OPTIS™C408646C4086462015-04-20
05415067037626Ultiri™101508210150822022-08-12
05415067031129Dragonfly OpStar™101465110146512019-12-17
00183739000678ILUMIEN™C408650C4086502016-03-23
00812059020126OPTIS™C408653C4086532015-09-28
05415067030856AptiVue™101466610146662020-10-26
00183739000937OPTIS™Integrated SystemC4086522015-09-28
00812059021420OPTIS™Mobile SystemC4086612015-12-21
00183739000562C7 Dragonfly™100-100-00100-100-002015-04-17
00183739000623Dragonfly™Kit100-100-KT2015-04-20
00183739000630ILUMIEN™900-700-00900-700-002016-03-23
00183739000692Dragonfly™Duo KitC4086432015-04-20
00183739000708Dragonfly™DuoC4086442015-04-20

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