FDA.reportPublic FDA data

Alembic Aspiration Tubing

Primary DI
00850014025007
Brand
Alembic Aspiration Tubing
Company
Alembic, LLC
Model
FG-01001
Published
2023-04-27
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
NRYCatheter, Thrombus Retriever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223545000
K230695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223545000APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-02-17NRY
K230695000APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-04-10NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014025007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014025007008500140250078500140250070850014025007

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place

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
00850014025083APRO 55 Intermediate CatheterAPRO-55IC-1252024-04-08
00850014025090APRO 55 Intermediate CatheterAPRO-55IC-1372024-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086475CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086499CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086512CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086536CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086550CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086598CEREGLIDECerenovus, Inc.NRY2025-09-26