FDA.reportPublic FDA data

PRESSANA

Primary DI
04960685205038
Brand
PRESSANA
Company
TORAY INDUSTRIES,INC.
Model
OPC-0315135
Published
2017-03-22
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14960685205035PackageGS11Not in Commercial Distribution
04960685205038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1496068520503514960685205035
04960685205038049606852050384960685205038

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced 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 superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Device Size Text, specify0
Length135Centimeter

Contacts#

Phone, Email table
PhoneEmail
2815872299xx@xx.xx

Regulatory Flags#

DUNS number
690535422
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14960685201228INOUE BALLOON APTAV-20R2023-06-01
14960685201235INOUE BALLOON APTAV-22R2023-06-01
14960685201242INOUE BALLOON APTAV-24R2023-06-01
14960685201259INOUE BALLOON APTAV-26R2023-06-01
14960685201341INOUE BALLOON APTAV-16R2023-06-01
14960685201358INOUE BALLOON APTAV-18R2023-06-01
14960685201389INOUE BALLOON APTAV-16RP2023-06-01
14960685201396INOUE BALLOON APTAV-18RP2023-06-01
14960685201402INOUE BALLOON APTAV-20RP2023-06-01
14960685201419INOUE BALLOON APTAV-22RP2023-06-01
14960685201426INOUE BALLOON APTAV-24RP2023-06-01
14960685201433INOUE BALLOON APTAV-26RP2023-06-01
04960685205021PRESSANAOPC-03081352017-03-22
04960685205427PRESSANAOPC-07081352017-03-22
04960685200781TORAYGUIDE GUIDEWIRETRG-251752016-07-22
14960685200030Inoue Balloon CatheterPTMC-262014-09-17
14960685200047Inoue Balloon CatheterPTMC-282014-09-17
14960685200054Inoue Balloon CatheterPTMC-302014-09-17
04960685200798TORAYGUIDE GUIDEWIRETRG-252302016-07-22
14960685205028PRESSANAOPC-03081352017-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
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00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16