FDA.reportPublic FDA data

Quick-Cross Support Catheter

Primary DI
00813132020682
Brand
Quick-Cross Support Catheter
Company
Spectranetics Corporation
Model
518-037
Catalog number
518-037
Published
2015-02-06
Public version status
Update
Distribution status
Not 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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033678000SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038Spectranetics Corp.2004-02-23DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813132020686PackageGS15In Commercial Distribution
00813132020682PrimaryGS10
M204518037AA0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081313202068620813132020686
00813132020682008131320206828131320206820813132020682

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Centimeter
Lumen/Inner Diameter0.035Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-633-0960complaints@spnc.com
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132020293SLS II Laser Sheath500-001500-0012015-02-06
00813132020309SLS II Laser Sheath500-012500-0122015-02-06
00813132020316SLS II Laser Sheath500-013500-0132015-02-06
00813132020903SightRail Manual Dilator Sheath550-008550-0082015-02-06
00813132020910SightRail Manual Dilator Sheath550-010550-0102015-02-06
00813132020927SightRail Manual Dilator Sheath550-011550-0112015-02-06
00813132020934SightRail Manual Dilator Sheath550-013550-0132015-02-06
00813132020941SightRail Manual Dilator Sheath555-508555-5082015-02-06
00813132020958SightRail Manual Dilator Sheath555-510555-5102015-02-06
00813132020965SightRail Manual Dilator Sheath555-511555-5112015-02-06
00813132020972SightRail Manual Dilator Sheath555-513555-5132015-02-06
00813132020002ELCA™110-001AA110-0012015-02-06
00813132020019ELCA™110-002AA110-0022015-02-06
00813132020026ELCA™110-003AA110-0032015-02-06
00813132020064ELCA™117-205AA117-2052015-02-06
00813132020071ELCA™120-008AA120-0082015-02-06
00813132025410ELCA™120-008AB120-0082017-12-04
00813132025427ELCA™117-205AB117-2052017-12-04
00813132025465ELCA™110-003AB110-0032017-12-04
00813132025472ELCA Coronary Laser Atherectomy Catheter110-002110-0022017-12-04

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