PHOENIX ATHERECTOMY CATHETER, 1.5MM X 149CM, 4F

GUDID 00845225003166

VOLCANO ATHEROMED, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00845225003166
NIH Device Record Keyfe045838-b4e9-4e41-9165-9f596b261844
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHOENIX ATHERECTOMY CATHETER, 1.5MM X 149CM, 4F
Version Model NumberP15149
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 Kitfalse
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 Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 Millimeter
Length149 Centimeter
Outer Diameter1.5 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
GS100845225003166 [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 Date2021-11-03
Device Publish Date2021-10-26

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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