FDA.reportPublic FDA data

Guidewire Introducer Needle

Primary DI
M661S013182759
Brand
Guidewire Introducer Needle
Company
Spectra Medical Devices, LLC
Model
S013182759L
Device description
"18G x 2.75"" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator"
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082580000SPECTRA GUIDEWIRE INTRODUCER NEEDLESpectra Medical Devices, Inc.2008-12-08DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M661S013182759PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118301171
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleS103417-3.50NL2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleS103418-3.50LT2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleS10341-8.500LT2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleS80C21-6.00BLX2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleS80C22-2.00BLX2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleS80C23-2.00BL2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleS90C22-6.00BLX2024-06-18
M661S80C21200MSK Ultrasonic Injection NeedleS80C21-2.00BLX2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleS80C21-4.00BLX2024-02-12
M661SST221505Radiofrequency (RF) NeedleSST221505SL2024-06-18
M661S075173501Plastic Standard Hub Tuohy Epidural NeedleS07517-3.501B2024-06-18
M661S075175001Plastic Standard Hub Tuohy Epidural NeedleS07517-5.001B2024-06-18
M661S075183501Plastic Standard Hub Tuohy Epidural NeedleS07518-3.501B2024-06-18
M661S075185001Plastic Standard Hub Tuohy Epidural NeedleS07518-5.001B2024-06-18
M661S135143508Metal Standard Hub Tuohy Epidural NeedleS13514-3.508C2024-06-18
M661S135144008Metal Standard Hub Tuohy Epidural NeedleS13514-4.008C2024-06-18
M661S135173008Metal Standard Hub Tuohy Epidural NeedleS13517-3.008B2024-06-18
M661S135173508Metal Standard Hub Tuohy Epidural NeedleS13517-3.508A2024-06-18
M661S135173828Metal Standard Hub Tuohy Epidural NeedleS13517-3.828A2024-06-18
M661S135175008Metal Standard Hub Tuohy Epidural NeedleS13517-5.008A2024-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
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
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
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04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
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
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30