Captus Vascular Retrieval System
Basic Information
- Brand Name
- Captus Vascular Retrieval System
- Primary DI
- B342CAP14120
- Version / Model
- CAP1412
- Company Name
- Avantec Vascular Corporation
- Labeler DUNS
- 797246308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-13
- Public Version
- 1
- Public Version Date
- 2021-07-21
- Public Version Status
- New
- Public Device Record Key
- 1b456ec7-310b-4a12-a9bd-946e0fcf7eeb
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65609 | Intravascular extraction catheter-net | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B342CAP14120 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170987 | 000 |