Pantheris LV A110-LV

GUDID 00851354004578

The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only.

AVINGER, INC.

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Primary Device ID00851354004578
NIH Device Record Keyb303be41-845c-43b7-b16f-39c0f650d7b3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePantheris LV
Version Model NumberLV
Catalog NumberA110-LV
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 Kitfalse
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 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com
Phone650 241 7900
Emailcustomerservice@avinger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

Devices Manufactured by AVINGER, INC.

00851354004509 - Lightbox L32024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de
00851354004578 - Pantheris LV2024-02-06The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only.
00851354004578 - Pantheris LV2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F
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 SV2019-08-12 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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