FDA.reportPublic FDA data

Celt ACD Vascular Closure Device 7F

Primary DI
05391530280129
Brand
Celt ACD Vascular Closure Device 7F
Company
VASORUM LIMITED
Model
KCLT-07
Device description
Celt ACD Vascular Closure Device 7F
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MGBDevice, Hemostasis, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGBDevice, Hemostasis, VascularUnknown3

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
05391530280136PackageGS15In Commercial Distribution
05391530280143PackageGS14In Commercial Distribution
05391530280129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530280136053915302801365391530280136
05391530280143053915302801435391530280143
05391530280129053915302801295391530280129

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 Gauge7French

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
05391530280006Celt ACD Vascular Closure Device 5FKCLT-052017-07-21
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
05391530280150Celt ACD Vascular Closure Device 7F_ESPKCLT-072017-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7298001014XL0VASCADE MVP XL VVCSCARDIVA MEDICAL, INC.MGB2026-05-18
10841156111335MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111359MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111373MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156103439D-STATTELEFLEX INCORPORATEDMGB2025-07-16
20841156103436D-STATTELEFLEX INCORPORATEDMGB2025-07-16
05391530280617Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FVASORUM LIMITEDMGB2025-04-24
10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109929MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109936MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109950MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109902MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109926MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109933MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109957MANTATELEFLEX INCORPORATEDMGB2024-09-09
10705032090278MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
20705032090275MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
10841156109080D-STATTELEFLEX INCORPORATEDMGB2023-12-11
20841156109087D-STATTELEFLEX INCORPORATEDMGB2023-12-11
00856279007307MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007321MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007345MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007369MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23