FDA.reportPublic FDA data

Vascette HP

Primary DI
00860003147900
Brand
Vascette HP
Company
Koag International LLC
Model
CP-80000
Catalog number
CP-80000
Device description
Vascette HP is a single-use, hemostatic dressing incorporating a plant-based, polysaccharide, hemostatic foam agent. Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
Published
2025-11-25
Public version status
New
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
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220566000Vascette HP (hemostatic pad)Koag, LLC2022-07-29QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860003147907PackageGS110In Commercial Distribution
00860003147900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000314790710860003147907
00860003147900008600031479008600031479000860003147900

GMDN Terms#

Term, Definition table
TermDefinition
Surgical haemostatic agent/anti-adhesion material, animal-derivedA bioabsorbable implantable membrane comprised of polysaccharides [at least one animal-derived (e.g., chitin)] intended to be topically applied to superficial surgical wounds or optionally implanted around internal surgical wounds to facilitate local haemostasis, and to function internally as a barrier to reduce the incidence of adhesions between adjacent anatomical structures. It is in the form of a paper-like membrane applied directly to the wound where it takes the form of a gel upon wound adherence and eventually biodegrades; neither antimicrobials nor pharmaceuticals are included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
470-755-9291dlang@koag.life

Regulatory Flags#

DUNS number
074533858
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860003147907Vascette HPCP-80000CP-800002025-11-25

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Primary DI, Brand, Company table
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