FDA.reportPublic FDA data

APRO 45 Intermediate Catheter

Primary DI
00850014025397
Brand
APRO 45 Intermediate Catheter
Company
Alembic, LLC
Model
FG-02273-115-IC
Catalog number
APRO-45IC-115
Device description
APRO 45 Intermediate Catheter, Hooped Configuration
Published
2026-03-25
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

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
K251014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251014000APRO 45 CatheterAlembic, LLC2025-05-01DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014025397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014025397008500140253978500140253970850014025397

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
065914268
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
true
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
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
00850014025243APRO 55 Intermediate CatheterFG-01681-N25-ICAPRO-55IC-1252025-06-30
00850014025281APRO 55 Intermediate CatheterFG-01681-N37-ICAPRO-55IC-1372025-06-30
00850014025229APRO 70 Swift CatheterFG-02133-132-ICAPRO-70-1322025-03-04
00850014025083APRO 55 Intermediate CatheterAPRO-55IC-1252024-04-08
00850014025090APRO 55 Intermediate CatheterAPRO-55IC-1372024-04-08
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
00850014025236APRO 55 Swift CatheterFG-01681-N37-ACAPRO-55-1372025-06-30
00850014025274APRO 55 Swift CatheterFG-01681-N25-ACAPRO-55-1252025-06-30
00850014025113APRO 70 SwiftCatheterFG-02133-125-ACAPRO-70-1252025-03-04
00850014025120APRO 70 Swift CatheterFG-02133-135-ACAPRO-70-1352025-03-04
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
00850014025250APRO 55 CatheterAPRO-55-1252024-04-08

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Primary DI, Brand, Company table
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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
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
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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