FDA.reportPublic FDA data

MicroTaper™ Safety Introducer Set

Primary DI
20860327000213
Brand
MicroTaper™ Safety Introducer Set
Company
SUMMIT ACCESS LLC
Model
SA-03-G060
Published
2016-09-09
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

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
20860327000213PackageGS110In 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 sterile, 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
021348782
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
10860327000216MicroTaper™ Safety Introducer Set SA-03-G0602016-09-09
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
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
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