FDA.reportPublic FDA data

Celt ACD Vascular Closure Device 5F

Primary DI
05391530280006
Brand
Celt ACD Vascular Closure Device 5F
Company
VASORUM LIMITED
Model
KCLT-05
Device description
Celt ACD Vascular Closure Device 5F
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150006001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150006001CELT ACD VASCULAR CLOSURE DEVICEVasorum, Ltd.2016-07-20MGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530280013PackageGS15In Commercial Distribution
05391530280020PackageGS14In Commercial Distribution
05391530280006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530280013053915302800135391530280013
05391530280020053915302800205391530280020
05391530280006053915302800065391530280006

GMDN Terms#

Term, Definition table
TermDefinition
Vascular closure clipA non-bioabsorbable metallic clip intended to be implanted following a percutaneous catheterization procedure to close the punctured access site on an artery (typically femoral) and improve haemostasis. It is typically a small circular clip with grasping blades intended to close inwardly upon deployment; dedicated disposable devices (e.g., applicator) intended for implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep out of direct sunlight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896197592
Device count
1
Kit
true
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
05391530280617Celt ACD PLUS Vascular Closure Device 5FCLT-052025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FCLT-062025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FCLT-052025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FCLT-062025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FCLT-072025-04-24
05391530280037Celt ACD Vascular Closure Device 5F_ESPKCLT-052017-07-21
05391530280068Celt ACD Vascular Closure Device 6FKCLT-062017-07-21
05391530280099Celt ACD Vascular Closure Device 6F_ESPKCLT-062017-07-21
05391530280129Celt ACD Vascular Closure Device 7FKCLT-072017-07-21
05391530280150Celt ACD Vascular Closure Device 7F_ESPKCLT-072017-07-21