FDA.reportPublic FDA data

Quick-Cross Support Catheter

Primary DI
00813132029395
Brand
Quick-Cross Support Catheter
Company
Philips Image Guided Therapy Corporation
Model
518-065
Catalog number
518-065
Published
2022-02-22
Public version status
Update
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
K072750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072750000SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066Spectranetics Corp.2007-12-04DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813132029399PackageGS15In Commercial Distribution
00813132029395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081313202939920813132029399
00813132029395008131320293958131320293950813132029395

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@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
false
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
00813132029326Quick-Cross Support Catheter518-032518-0322022-02-22
00813132029333Quick-Cross Support Catheter518-033518-0332022-02-22
00813132029340Quick-Cross Support Catheter518-034518-0342022-02-22
00813132029357Quick-Cross Support Catheter518-035518-0352022-02-22
00813132029364Quick-Cross Support Catheter518-036518-0362022-02-22
00813132029371Quick-Cross Support Catheter518-037518-0372022-02-22
00813132029388Quick-Cross Support Catheter518-038518-0382022-02-22
00813132029401Quick-Cross Support Catheter518-066518-0662022-02-22
00813132029418Quick-Cross Extreme Support Catheter518-084518-0842023-10-04
00813132029425Quick-Cross Extreme Support Catheter518-086518-0862023-10-04
00813132029432Quick-Cross Extreme Support Catheter518-088518-0882023-10-04
00813132029449Quick-Cross Extreme Support Catheter518-090518-0902023-10-04
00813132029456Quick-Cross Extreme Support Catheter518-092518-0922023-10-04
00813132029470Quick-Cross Extreme Support Catheter518-078518-0782023-10-04
00813132029487Quick-Cross Extreme Support Catheter518-080518-0802023-10-04
00813132029494Quick-Cross Extreme Support Catheter518-082518-0822023-10-04
00813132029517Quick-Cross Select Support Catheter518-085518-0852023-10-04
00813132029524Quick-Cross Select Support Catheter518-087518-0872023-10-04
00813132029531Quick-Cross Select Support Catheter518-089518-0892023-10-04
00813132029548Quick-Cross Select Support Catheter518-091518-0912023-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16