FDA.reportPublic FDA data

Vascular Dilator Kit

Primary DI
00803622112522
Brand
Vascular Dilator Kit
Company
LIVANOVA USA, INC.
Model
200-120
Published
2014-12-22
Public version status
Update
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070749000ESTECH PERCUTANEOUS INSERTION DILATOR KITCoombs Medical Device Consulting2007-10-24DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00803622112522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00803622112522008036221125228036221125220803622112522

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
080914995
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163982Perfusion PackPerfusion Pack2026-07-17
00803622164071Perfusion PackPerfusion Pack2026-07-17
00803622164118Perfusion PackPerfusion Pack2026-07-17
00803622163623Perfusion PackPerfusion Pack2026-07-10
00803622163906Perfusion PackPerfusion Pack2026-07-10
00803622163975Perfusion PackPerfusion Pack2026-07-10
00803622163999Perfusion PackPerfusion Pack2026-07-10
00803622164002Perfusion PackPerfusion Pack2026-07-10
00803622119484Cardioplegia PackCardioplegia Pack2015-04-22
00803622163524Perfusion PackPerfusion Pack2026-07-08
00803622120138Perfusion PackPerfusion Pack2015-04-22
00803622163937Perfusion PackPerfusion Pack2026-06-26
00803622164019Perfusion PackPerfusion Pack2026-06-26
05425025750870VNS Therapy™ Programmer, Model 3100 v2.1.031002026-06-24
00803622163715Perfusion PackPerfusion Pack2026-06-08
00803622163722Perfusion PackPerfusion Pack2026-06-08
00803622163586Perfusion PackPerfusion Pack2026-05-27
00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27

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Primary DI, Brand, Company table
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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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