Captus Vascular Retrieval System

Primary DI
B342CAP14120
Brand
Captus Vascular Retrieval System
Company
Avantec Vascular Corporation
Model
CAP1412
Device description
The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MMXDevice, Percutaneous Retrieval

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMXDevice, Percutaneous RetrievalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170987000Captus Vascular Retrieval SystemAvantec Vascular Corporation2017-08-28MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B342CAP14120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular extraction catheter-netA long, thin flexible tube with a distal funnel-shaped net and a circular cross-haired element intended to be inserted into the vasculature (artery/vein) to manually grasp and remove either unintentionally-introduced foreign bodies (e.g., sheared cannula tips) or intentionally-introduced devices (e.g., filters), using controls in the device handle. It may be introduced as an emergency measure during a cardiovascular procedure (e.g., cardiac catheterization) through the procedural site/instruments, or during an elective procedure, under fluoroscopic control. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797246308
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
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00850041730141LimFlow V-CeiverInari Medical, Inc.MMX2024-03-09
20827002132874Gunther TulipCOOK INCORPORATEDMMX2023-12-04
00860008180605ONO Retrieval DeviceOnocor LLCMMX2023-08-04
00850041730004LimFlow V-CeiverInari Medical, Inc.MMX2023-06-26
00884450681732ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
10884450681739ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
05415067034496Aveir™ST. JUDE MEDICAL, INC.MMX2023-03-03
00884450681749ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
10884450681746ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
00884450681848ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
10884450681845ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
00884450681725ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
10884450681722ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
00884450681718ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
10884450681715ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
00884450681787ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
10884450681784ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
00884450681763ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
00884450681800ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16