Angel Catheter

Primary DI
B077AC3930A1
Brand
Angel Catheter
Company
BIO2 MEDICAL INC
Model
AC3930A
Device description
The Angel® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC).
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
B077AC3930A5PackageHIBCC5In Commercial Distribution
B077AC3930A1PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+4547108570customer@mermaidmedical.com

Regulatory Flags#

DUNS number
019935020
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055005002Angel CatheterMermaid Medical A/SPNS2022-09-28