FDA.reportPublic FDA data

AVANTI

Primary DI
10705032010368
Brand
AVANTI
Company
CORDIS CORPORATION
Model
504656A
Catalog number
504656A
Device description
CSI AVANTI+ CARDIOLOGY MS .038
Published
2016-08-01
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
K970392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970392000CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEMCordis Corp.1997-04-24DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032010365PackageGS15In Commercial Distribution
10705032010368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503201036520705032010365
1070503201036810705032010368

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designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications.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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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