Phoenix Atherectomy System, 1.8mm X 149cm Kit

GUDID 00845225002725

VOLCANO ATHEROMED, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00845225002725
NIH Device Record Keyf8e44ca0-00c4-44b2-b9c4-c48aaef852fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoenix Atherectomy System, 1.8mm X 149cm Kit
Version Model NumberP18149K
Company DUNS788341084
Company NameVOLCANO ATHEROMED, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Dimensions

Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter
Outer Diameter1.8 Millimeter
Length149 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225002725 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by VOLCANO ATHEROMED, INC.

00845225003463 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.5mm x 149cm, 4F
00845225003470 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 130cm, 5F
00845225003487 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 149cm, 5F
00845225003494 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 130cm, 6F
00845225003500 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 149cm, 6F
00845225003517 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.2mm x 130cm, 6F
00845225003524 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.4mm x 130cm, 7F
00845225003531 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy System, 1.5mm x 149cm, 4F
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