Pantheris SV A140-SV

GUDID 00851354004417

The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

AVINGER, INC.

Mechanical atherectomy system, coronary/peripheral
Primary Device ID00851354004417
NIH Device Record Key75802b75-b0c6-4612-b342-d118b1801e07
Commercial Distribution StatusIn Commercial Distribution
Brand NamePantheris SV
Version Model NumberA140-SV
Catalog NumberA140-SV
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-241-7030
Emailtlawson@avinger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00851354004417]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-12
Device Publish Date2019-08-02

Devices Manufactured by AVINGER, INC.

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00851354004554 - Tigereye ST2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions
00851354004493 - Tigereye2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
00851354004417 - Pantheris SV2019-08-12The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.
00851354004417 - Pantheris SV2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature
00851354004004 - Wildcat2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
00851354004028 - Wildcat2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
00851354004042 - Kittykat II2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It

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