FDA.reportPublic FDA data

Odyssey Micro Catheter

Primary DI
00857834006605
Brand
Odyssey Micro Catheter
Company
HERAEUS MEDICAL COMPONENTS LLC
Model
OMC-007
Published
2018-03-12
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170664000Odyssey Micro CatheterHeraeus Medical Components, LLC2017-11-09DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857834006605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857834006605008578340066058578340066050857834006605

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
868303074
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002448469Motion Hybrid Wire GuideMHW-0351502021-09-09
00827002448483Motion Hybrid Wire GuideMHW-0381502021-09-09
00827002448490Motion Hybrid Wire GuideMHWA-0381502021-09-09
00827002448551Motion Hybrid Wire GuideMHWA-0351502021-09-09
08714729892038NovaGold5200M005520002016-09-21
08714729892045NovaGold5201M005520102016-09-21
00857834006070ERCPGI1012016-09-21
00857834006087ERCPGI1022016-09-21
00857834006094ERCPGI1032016-09-21
00857834006100ERCPGI1042016-09-21
00857834006117ERCPGI1052016-09-21
00857834006124ERCPGI1062016-09-21
00857834006131ERCPGI1072016-09-21
00857834006148ERCPGI1082016-09-21
00857834006155ERCPGI1092016-09-21
00857834006162ERCPGI1102016-09-21
00857834006179ERCPGI1112016-09-21
00857834006186ERCPGI1122016-09-21
00857834006193ERCPGI1132016-09-21
00857834006209ERCPGI1142016-09-21

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Primary DI, Brand, Company table
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