FDA.reportPublic FDA data

MicroTaper™ Safety Introducer Set

Primary DI
10860327000216
Brand
MicroTaper™ Safety Introducer Set
Company
SUMMIT ACCESS LLC
Model
SA-03-G060
Published
2016-09-09
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

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151076000MicroTaper Needle Introducer SetSummit Access, LLC2015-05-22DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860327000213PackageGS110Not in Commercial Distribution
10860327000216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086032700021320860327000213
1086032700021610860327000216

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.

Regulatory Flags#

DUNS number
021348782
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860327000223MicroTaper™ Safety Introducer Set SA-04-G0602016-09-09
10860327000230MicroTaper™ Safety Introducer Set SA-07-G0602016-09-09
10860327000247MicroTaper™ Safety Introducer Set SA-10-G0602016-09-09
10860327000254MicroTaper™ Safety Introducer Set SA-15-G0602016-09-09
10860327000278MicroTaper™ NV Non-Vascular Safety Introducer Set SA-15-G100-NT-MT2022-10-05
10860327000285MicroTaper™ NV Non-Vascular Safety Introducer Set SA-15-G100-NT2022-10-05
10860327000292MicroTaper™ NV Non-Vascular Safety Introducer Set SA-15-G100-NT-ST2022-10-05
20860327000213MicroTaper™ Safety Introducer Set SA-03-G0602016-09-09
20860327000220MicroTaper™ Safety Introducer Set SA-04-G0602016-09-09
20860327000237MicroTaper™ Safety Introducer Set SA-07-G0602016-09-09
20860327000244MicroTaper™ Safety Introducer Set SA-10-G0602016-09-09
20860327000251MicroTaper™ Safety Introducer Set SA-15-G0602016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDRE2023-09-01