FDA.reportPublic FDA data

Vascette HP

Primary DI
10860003147907
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
OTC
false
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003147900Vascette HPCP-80000CP-800002025-11-25

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