FDA.reportPublic FDA data

APRO 55 Intermediate Catheter

Primary DI
00850014025083
Brand
APRO 55 Intermediate Catheter
Company
Alembic, LLC
Model
APRO-55IC-125
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234115000APRO 55 CatheterAlembic, LLC2024-03-15DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014025083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014025083008500140250838500140250830850014025083

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065914268
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014025182APRO 45 Swift CatheterFG-02273-115-ACAPRO-45-1152026-03-25
00850014025199APRO 45 Swift CatheterFG-02273-125-ACAPRO-45-1252026-03-25
00850014025205APRO 45 Swift CatheterFG-02273-146-ACAPRO-45-1462026-03-25
00850014025212APRO 45 Swift CatheterFG-02273-160-ACAPRO-45-1602026-03-25
00850014025397APRO 45 Intermediate CatheterFG-02273-115-ICAPRO-45IC-1152026-03-25
00850014025403APRO 45 Intermediate CatheterFG-02273-125-ICAPRO-45IC-1252026-03-25
00850014025410APRO 45 Intermediate CatheterFG-02273-146-ICAPRO-45IC-1462026-03-25
00850014025427APRO 45 Intermediate CatheterFG-02273-160-ICAPRO-45IC-1602026-03-25
00850014025236APRO 55 Swift CatheterFG-01681-N37-ACAPRO-55-1372025-06-30
00850014025243APRO 55 Intermediate CatheterFG-01681-N25-ICAPRO-55IC-1252025-06-30
00850014025274APRO 55 Swift CatheterFG-01681-N25-ACAPRO-55-1252025-06-30
00850014025281APRO 55 Intermediate CatheterFG-01681-N37-ICAPRO-55IC-1372025-06-30
00850014025113APRO 70 SwiftCatheterFG-02133-125-ACAPRO-70-1252025-03-04
00850014025120APRO 70 Swift CatheterFG-02133-135-ACAPRO-70-1352025-03-04
00850014025229APRO 70 Swift CatheterFG-02133-132-ICAPRO-70-1322025-03-04
00850014025267APRO 70 Swift CatheterFG-02133-132-ACAPRO 70-1322025-03-04
00850014025069APRO 70 CatheterFG-01016-N32APRO 70-1322024-07-22
00850014025052APRO 55 CatheterAPRO-55-1372024-04-08
00850014025090APRO 55 Intermediate CatheterAPRO-55IC-1372024-04-08
00850014025250APRO 55 CatheterAPRO-55-1252024-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902189452ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902218145ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219692ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20