FDA.reportPublic FDA data

PRESSANA

Primary DI
14960685205028
Brand
PRESSANA
Company
TORAY INDUSTRIES,INC.
Model
OPC-0308135
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14960685205028PackageGS11In Commercial Distribution
04960685205021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1496068520502814960685205028
04960685205021049606852050214960685205021

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
Catheter Gauge6French
Device Size Text, specify0
Length135Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2815872299xx@xx.xx

Regulatory Flags#

DUNS number
690535422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04960685205038PRESSANAOPC-03151352017-03-22
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

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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00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16