FDA.reportPublic FDA data

HAART

Primary DI
10857160006284
Brand
HAART
Company
Corcym Inc.
Model
300-21US
Catalog number
300-21US
Device description
Aortic Annuloplasty Device
Published
2017-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSTAortic Annuloplasty Ring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSTAortic Annuloplasty RingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163608000HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mmBiostable Science & Engineering, Inc.2017-03-21PST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857160006284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085716000628410857160006284

GMDN Terms#

Term, Definition table
TermDefinition
Aortic annuloplasty ringA circular band intended to be implanted in the heart to support an aortic valve annulus for the reconstruction and/or remodelling of an insufficient aortic valve. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation, which may involve a specialized handle, with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5129709112julie.thomas@biostable-s-e.com

Regulatory Flags#

DUNS number
112833663
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857160006314HAART301-00US301-00US2023-07-17
10857160006239HAART200-19US200-19US2017-09-27
10857160006246HAART200-21US200-21US2017-09-27
10857160006253HAART200-23US200-23US2017-09-27
10857160006260HAART200-25US200-25US2017-09-27
10857160006277HAART300-19US300-19US2017-05-15
10857160006291HAART300-23US300-23US2017-05-15
10857160006307HAART300-25US300-25US2017-05-15
10857160006338HAART Polyester Pledget 6-Pack100-06US100-06US2019-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857160006239HAARTCorcym Inc.PST2017-09-27
10857160006246HAARTCorcym Inc.PST2017-09-27
10857160006253HAARTCorcym Inc.PST2017-09-27
10857160006260HAARTCorcym Inc.PST2017-09-27
10857160006277HAARTCorcym Inc.PST2017-05-15
10857160006291HAARTCorcym Inc.PST2017-05-15
10857160006307HAARTCorcym Inc.PST2017-05-15