FDA.reportPublic FDA data

Phoenix 2.2mm x 149cm 6F Atherectomy System

Primary DI
00845225002732
Brand
Phoenix 2.2mm x 149cm 6F Atherectomy System
Company
Volcano Atheromed, Inc.
Model
P22149K
Catalog number
P22149K
Published
2016-09-01
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
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1433280001.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipVolcano Atheromed, Inc.2014-12-19MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002732008452250027328452250027320845225002732

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length149Centimeter
Outer Diameter2.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
788341084
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225003104QuickClear Thrombectomy SystemAC8ST085AC8ST0852022-01-19
00845225003005QuickClear Aspiration PumpP3223ASPP3223ASP2020-06-11
00845225003012QuickClear Aspiration PumpP3223P32232020-06-11
00845225003081QuickClear Thrombectomy SystemAC6ST130AC6ST1302020-06-11
00845225003128QuickClear Thrombectomy SystemAC8SH085AC8SH0852020-06-11
00845225003142QuickClear Thrombectomy SystemAC10SH085AC10SH0852020-06-11
00845225003180Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy CatheterPD24130PD241302021-10-26
00845225003197Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy SystemPD24130KPD24130K2021-10-26
00845225002985Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy CatheterPD22130PD221302019-03-07
00845225002992Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy SystemPD22130K PD22130K2019-03-07
00845225003166Phoenix 1.5mm x 149cm 4F Atherectomy CatheterP15149P151492021-10-26
00845225003173Phoenix 1.5mm x 149cm 4F Atherectomy SystemP15149KP15149K2021-10-26
00845225002619Phoenix 1.8mm x 130cm 5F Atherectomy CatheterP18130P181302016-09-01
00845225002626Phoenix 2.2mm x 130cm 6F Atherectomy CatheterP22130P221302016-09-01
00845225002633Phoenix 2.4mm 7F Deflecting Atherectomy CatheterPD24127PD241272016-09-01
00845225002640Phoenix 1.8mm x 149cm 5F Atherectomy CatheterP18149P181492016-09-01
00845225002657Phoenix 2.2mm x 149cm 6F Atherectomy CatheterP22149P221492016-09-01
00845225002695Phoenix 1.8mm x 130cm 5F Atherectomy SystemP18130KP18130K2016-09-01
00845225002701Phoenix 2.2mm x 130cm 6F Atherectomy SystemP22130KP22130K2016-09-01
00845225002718Phoenix 2.4mm 7F Deflecting Atherectomy SystemPD24127KPD24127K2016-09-01

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