FDA.reportPublic FDA data

Axiom® Femoral Venous

Primary DI
M6651003600
Brand
Axiom® Femoral Venous
Company
AXIOM MEDICAL, INCORPORATED
Model
100360
Device description
Femoral Venous Catheter, Silicone
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842084000AXIOM FEMORAL VENUS CATHETERAxiom Medical, Inc.1984-08-01DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6651003601PackageHIBCC5In Commercial Distribution
M6651003603PackageHIBCC6In Commercial Distribution
M6651003600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
310-533-9020Sales@AxiomMed.com

Regulatory Flags#

DUNS number
094439676
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6651000080Axiom®1000082016-09-23
M665100008AT0Axiom® Atraum™ With ClotStop®100008AT2018-09-23
M665100008ATS0Axiom® Atraum™ With ClotStop®100008ATS2018-09-23
M665100008ATSC0Axiom® Atraum™ With ClotStop®100008ATSC2018-09-23
M665100008S0Axiom®100008S2016-09-23
M665100008SC0Axiom®100008SC2016-09-23
M6651000100Axiom®1000102016-09-23
M665100010AT0Axiom® Atraum™ With ClotStop®100010AT2018-09-23
M665100010ATS0Axiom® Atraum™ With ClotStop®100010ATS2018-09-23
M665100010ATSC0Axiom® Atraum™ With ClotStop®100010ATSC2018-09-23
M665100010S0Axiom®100010S2016-09-23
M665100010SC0Axiom®100010SC2016-09-23
M6651000120Axiom®1000122016-09-23
M665100012AT0Axiom® Atraum™ With ClotStop®100012AT2018-09-23
M665100012ATS0Axiom® Atraum™ With ClotStop®100012ATS2018-09-23
M665100012ATSC0Axiom® Atraum™ With ClotStop®100012ATSC2018-09-23
M665100012S0Axiom®100012S2016-09-23
M665100012SC0Axiom®100012SC2016-09-23
M6651000140Axiom®1000142016-09-23
M665100014AT0Axiom® Atraum™ With ClotStop®100014AT2018-09-23

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Primary DI, Brand, Company table
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00199150070145NAMEDTRONIC, INC.DQY2026-04-13
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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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