FDA.reportPublic FDA data

Ocelot III

Primary DI
00851354004189
Brand
Ocelot III
Company
AVINGER, INC.
Model
O200
Catalog number
O200
Device description
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Published
2019-03-21
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
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122380000OCELOT SYSTEMAvinger, Inc.2012-11-07PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851354004189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851354004189008513540041898513540041890851354004189

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system, coronary/peripheralAn assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
650-241-7030tlawson@avinger.com

Regulatory Flags#

DUNS number
003152968
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851354004417Pantheris SVA140-SVA140-SV2019-08-02
00851354004233Ocelot IVO250O2502019-03-21
00851354004271CO2C100C1002019-03-21
00851354004370PantherisA400A4002019-03-21
00851354004387Pantheris A400XA400X2019-03-21
00851354004554Tigereye STO350O3502023-07-24
00851354004493TigereyeO300O3002023-03-14
00851354004509Lightbox L3L300L3002024-01-29
00851354004578Pantheris LVLVA110-LV2024-01-29
00851354004264Sterile DrapeSD100SD1002019-03-21
00851354004004WildcatW400W4002019-03-21
00851354004028WildcatE400E4002019-03-21
00851354004042Kittykat IIW550`W5502019-03-21
00851354004059Kittykat IIE550E5502019-03-21
00851354004073JuiceboxJ100J1002019-03-21
00851354004127Lightbox Umbilical U100U1002019-03-21
00851354004141Ocelot PIXLP135P1352019-03-21
00851354004301Lightbox Umbilical U250U2502019-03-21

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Primary DI, Brand, Company table
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08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
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10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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