FDA.reportPublic FDA data

Quick-Access™

Primary DI
M2045190050
Brand
Quick-Access™
Company
Spectranetics Corporation
Model
519-005
Catalog number
519-005
Device description
Quick-Access™ Needle Holder
Published
2014-08-26
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112887000UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORUpstream Peripheral Technologies2012-03-21DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2045190051PackageHIBCC5Not in Commercial Distribution
M2045190050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access kit, single-useA collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-633-0960www.complaints@spnc.com

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2045180320Quick-Cross™518-032518-0322014-08-19
M2045180330Quick-Cross™518-033518-0332014-08-19
M2045180340Quick-Cross™518-034518-0342014-08-19
M2045180350Quick-Cross™518-035518-0352014-08-19
M2045180360Quick-Cross™518-036518-0362014-08-19
M2045180370Quick-Cross™518-037518-0372014-08-19
M2045180380Quick-Cross™518-038518-0382014-08-19
M2045180430Turbo-Booster™518-043518-0432014-09-15
M2045180630Turbo-Booster™518-063518-0632014-09-15
M2045180650Quick-Cross™518-065518-0652014-08-19
M2045180660Quick-Cross™518-066518-0662014-08-19
M2045180760Quick-Cross™Extreme™518-076518-0762014-08-26
M2045180770Quick-Cross™Select518-077518-0772014-08-26
M2045180780Quick-Cross™Extreme™518-078518-0782014-08-26
M2045180790Quick-Cross™Select518-079518-0792014-08-26
M2045180800Quick-Cross™Extreme™518-080518-0802014-08-26
M2045180810Quick-Cross™Select518-081518-0812014-08-26
M2045180820Quick-Cross™Extreme™518-082518-0822014-08-26
M2045180830Quick-Cross™Select518-083518-0832014-08-26
M2045180840Quick-Cross™Extreme™518-084518-0842014-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
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04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
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04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
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