FDA.reportPublic FDA data

Quick-Cross Select

Primary DI
20813132029542
Brand
Quick-Cross Select
Company
Philips Image Guided Therapy Corporation
Model
518-091-B
Catalog number
518-091
Device description
Quick-Cross Select Support Catheter
Published
2023-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150201000Quick-Cross Extreme Support Catheter, Quick-Cross Select Support CatheterSpectranetics, Inc.2015-02-27DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813132029542PackageGS15In Commercial Distribution
00813132029548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081313202954220813132029542
00813132029548008131320295488131320295480813132029548

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Centimeter
Lumen/Inner Diameter0.018Inch

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
1-800-633-0960SPNC-complaints@philips.com

Regulatory Flags#

DUNS number
118354223
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225013011ICE PIMVSICEPIMVSICEPIM2026-07-30
00845225012939IntraSight Plus7974177974172026-05-26
00845225012946IntraSight Plus7974237974232026-05-26
00813132028824StellarexAB35SX040040080AB35SX0400400802022-01-05
00813132028763StellarexAB35SX060100135AB35SX0601001352022-01-13
00813132028770StellarexAB35SX040100135AB35SX0401001352022-01-13
00813132028787StellarexAB35SX040100080AB35SX0401000802022-01-13
00813132028794StellarexAB35SX050100080AB35SX0501000802022-01-13
00813132028800StellarexAB35SX060100080AB35SX0601000802022-01-13
00813132028817StellarexAB35SX050100135AB35SX0501001352022-01-13
00813132028831StellarexAB35SX040080080AB35SX0400800802022-01-13
00813132028848StellarexAB35SX040120080AB35SX0401200802022-01-13
00813132028855StellarexAB35SX050040080AB35SX0500400802022-01-13
00813132028862StellarexAB35SX050080080AB35SX0500800802022-01-13
00813132028879StellarexAB35SX050120080AB35SX0501200802022-01-13
00813132028886StellarexAB35SX060040080AB35SX0600400802022-01-13
00813132028893StellarexAB35SX060080080AB35SX0600800802022-01-13
00813132028909StellarexAB35SX060120080AB35SX0601200802022-01-13
00813132028916StellarexAB35SX040040135AB35SX0400401352022-01-13
00813132028923StellarexAB35SX040080135AB35SX0400801352022-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
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06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20