Angel Catheter

Primary DI
15711055005002
Brand
Angel Catheter
Company
Mermaid Medical A/S
Model
AC3930A
Device description
SHORT-TERM INTRAVASCULAR FILTER CATHETER
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNSShort-Term Intravascular Filter Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNSShort-Term Intravascular Filter CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160747000Angel CatheterBio2 Medical, Inc.2016-07-28PNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25711055005009PackageGS15In Commercial Distribution
15711055005002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2571105500500925711055005009
1571105500500215711055005002

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter, temporary/permanentA vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
308951313
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15711055000311M-DrainD13006015D130060152016-09-24
15711055000328M-DrainD13006020D130060202016-09-24
15711055000359M-DrainD13008025D130080252016-09-24
15711055000373M-DrainD13010025D130100252016-09-24
15711055000410M-DrainD14010040D140100402016-09-24
15711055000434M-DrainD14012040D140120402016-09-24
15711055000458M-DrainD14014040D140140402016-09-24
15711055000472M-DrainD14508040D145080402016-09-24
15711055000496M-DrainD14510040D145100402016-09-24
15711055000519M-DrainD14512040D145120402016-09-24
15711055000533M-DrainD14514040D145140402016-09-24
15711055000557M-DrainD10506025D105060252016-09-24
15711055000588M-DrainD10507020D105070202016-09-24
15711055000595M-DrainD10507025D105070252016-09-24
15711055000625M-DrainD10508020D105080202016-09-24
15711055000632M-DrainD10508025D105080252016-09-24
15711055000663M-DrainD10510020D105100202016-09-24
15711055000670M-DrainD10510025D105100252016-09-24
15711055000700M-DrainD10512025D105120252016-09-24
15711055000724M-DrainD10514025D105140252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B077AC3930A1Angel CatheterBIO2 MEDICAL INCPNS2016-09-09