FDA.reportPublic FDA data

Vascular Dilator Kit

Primary DI
00803622146947
Brand
Vascular Dilator Kit
Company
LIVANOVA USA, INC.
Model
200-120
Published
2020-08-19
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
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
00803622146947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00803622146947008036221469478036221469470803622146947

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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Regulatory Flags#

DUNS number
080914995
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
00803622112522Vascular Dilator Kit200-1202014-12-22
00803622164965Perfusion PackPerfusion Pack2026-10-22
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103056Cardioplegia cannulaAR-xxxxx2015-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450838105Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450839119Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450838143Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450839126Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450838204Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-02
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00884450839133Prelude Roadster™Merit Medical Systems, Inc.DRE2026-06-19
00884450839140Prelude Roadster™Merit Medical Systems, Inc.DRE2026-05-09
00884450838365Abiomed®Merit Medical Systems, Inc.DRE2025-07-01
00884450770764Prelude Roadster™Merit Medical Systems, Inc.DRE2023-12-13
00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
00884450770757Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-05
00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
00884450532522Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-15
00884450531952Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-12
00884450532348Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-01
00884450532171Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-28
00884450531914Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-19
00884450532607Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-01
00884450532515Prelude Roadster™Merit Medical Systems, Inc.DRE2022-09-14
00884450531921Prelude Roadster™Merit Medical Systems, Inc.DRE2022-09-13
00884450532065Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-30
00884450532591Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-30
00884450532553Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-23
00884450557501Prelude Roadster™Merit Medical Systems, Inc.DRE2022-08-23