FDA.reportPublic FDA data

Biotronik Passeo-35 HP

Primary DI
05391525781532
Brand
Biotronik Passeo-35 HP
Company
CREAGH MEDICAL LIMITED
Model
7/60/75
Catalog number
399089
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113468000ELM PTA BALLON DILATATION CATHETERCreagh Medical, Ltd.2011-12-20LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391525781532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391525781532053915257815325391525781532

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length60Millimeter
Outer Diameter7Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985021909
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391525787480Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-50-2202025-03-14
05391525787497Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-60-2202025-03-14
05391525787503Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-70-2202025-03-14
05391525785912Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200202021-10-20
05391525785929Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200402021-10-20
05391525785936Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200602021-10-20
05391525785943Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200802021-10-20
05391525785950Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201002021-10-20
05391525785967Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201202021-10-20
05391525785974Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201502021-10-20
05391525785981Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-202202021-10-20
05391525785998Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250202021-10-20
05391525786001Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250402021-10-20
05391525786018Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250602021-10-20
05391525786025Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250802021-10-20
05391525786032Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251002021-10-20
05391525786049Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251202021-10-20
05391525786056Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251502021-10-20
05391525786063Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-252202021-10-20
05391525786070Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-300202021-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
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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
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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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