FDA.reportPublic FDA data

CORDIS

Primary DI
10705032009591
Brand
CORDIS
Company
Cordis US Corp.
Model
502188
Catalog number
502188
Device description
ACCS OBTURATOR 4F 13.5CM
Published
2017-09-26
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914352000CORDIS OBTURATORCordis Corp.1991-11-22DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032009598PackageGS110In Commercial Distribution
10705032009591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200959820705032009598
1070503200959110705032009591

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032100557VISTA BRITE TIP588-842PM588-842PM2024-09-09
10705032100571VISTA BRITE TIP670-052-00M670-052-00M2024-09-09
10705032100595VISTA BRITE TIP670-002-00M670-002-00M2024-09-09
10705032100618VISTA BRITE TIP778-054-00M778-054-00M2024-09-09
10705032100625VISTA BRITE TIP670-034-00M670-034-00M2024-09-09
10705032100649VISTA BRITE TIP670-083-00M670-083-00M2024-09-09
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100670VISTA BRITE TIP670-036-00M670-036-00M2024-09-09
10705032100694VISTA BRITE TIP556-082-0LM556-082-0LM2024-09-09
10705032100700VISTA BRITE TIP670-110-00M670-110-00M2024-09-09
10705032100731VISTA BRITE TIP670-112-00M670-112-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100755VISTA BRITE TIP778-055-00M778-055-00M2024-09-09
10705032100762VISTA BRITE TIP670-055-00M670-055-00M2024-09-09
10705032100779VISTA BRITE TIP556-002-0LM556-002-0LM2024-09-09
10705032100793VISTA BRITE TIP556-080-0LM556-080-0LM2024-09-09
10705032100809VISTA BRITE TIP670-005-00M670-005-00M2024-09-09
10705032100816VISTA BRITE TIP556-054-0LM556-054-0LM2024-09-09
10705032100823VISTA BRITE TIP778-037-00M778-037-00M2024-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005452TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005469TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005476TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00685447005605SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005612SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005629SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005643SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10