FDA.reportPublic FDA data

VersaCross Transseptal Dilator

Primary DI
00685447004677
Brand
VersaCross Transseptal Dilator
Company
Baylis Médicale Cie Inc
Model
VCD85-35-95-D0
Published
2019-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190688000VersaCross Steerable Sheath, VersaCross Transseptal DilatorBaylis Medical Company, Inc.2019-04-17DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447004677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447004677006854470046776854470046770685447004677

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal dilatorA sterile device designed to be used with a transseptal introducer sheath to penetrate the interatrial septum to gain left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube made of plastic that is curved and round-nosed at the distal end to accommodate positioning against the atrial septum, and to accommodate in its lumen a Brockenbrough type curved puncture needle. It will typically have a marker (e.g., a hub) to identify the proximal portion of the dilator and to aid in placement of the sheath. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.5French
Device Size Text, specify0
Length95Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447006978Epicardial Steerable Guiding SheathESK85-35-BD-45SNA2022-07-21
00685447007623Epicardial Introducer and StyletEPI85-35-15-BSNA2022-07-21
00685447010487VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447010159VersaCross Steerable SheathVST00072022-05-09
00685447010166VersaCross Steerable SheathVST00092022-05-09
00685447010173VersaCross Steerable SheathVST00112022-05-09
00685447010180VersaCross Steerable SheathVST00132022-05-09
00685447010197VersaCross Steerable SheathVST00152022-05-09
00685447010203VersaCross Steerable SheathVST00172022-05-09
00685447010456SureFlex Steerable Guiding SheathTSK00072022-05-09
00685447010463SureFlex Steerable Guiding SheathTSK00092022-05-09
00685447010470SureFlex Steerable Guiding SheathTSK00112022-05-09
00685447005285TorFlex Transseptal Guiding SheathTF8-32-63-372021-11-01
00685447005292TorFlex Transseptal Guiding SheathTF8-32-63-452021-11-01
00685447005308TorFlex Transseptal Guiding SheathTF8-32-63-552021-11-01
00685447005315TorFlex Transseptal Guiding SheathTF8-32-63-902021-11-01
00685447005322TorFlex Transseptal Guiding SheathTF8-32-63-1352021-11-01
00685447005339TorFlex Transseptal Guiding SheathTF8-32-81-372021-11-01

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Primary DI, Brand, Company table
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