(140 days)
Not found
Not Found
No
The summary describes a purely mechanical device (catheter with a balloon) and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets, which are characteristic of AI/ML devices.
Yes
The device is intended for the removal of emboli and thrombi, which is a therapeutic intervention aimed at treating a medical condition.
No
The device description and intended use clearly state that it is for the removal of emboli and thrombi (treatment), not for diagnosis.
No
The device description clearly states it is a physical catheter with a balloon, tube, and stopcock, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal of arterial emboli and thrombi during embolectomy and thrombectomy." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for physical manipulation within the arterial system. This is a surgical/interventional device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. The provided description does not mention any such use or interaction with specimens.
Therefore, the Vaso-Safe Arterial Embolectomy Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.
Product codes
74 DXE
Device Description
The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial
Indicated Patient Age Range
P 19 Kids
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Fogarty Embolectorny Catheter
Reference Device(s)
Robicsek Angiography Embolectomy Catheters
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be a mix of letters and numbers, specifically 'K961716'. The handwriting style is somewhat stylized, with distinct strokes and curves forming each character. The image is in black and white, with the characters appearing in black against a white background.
SAFETY and EFFECTIVENESS SUMMARY
PROPRIETARY NAME:
P 19 Kids
Vaso-Safe Arterial Embolectomy Catheter
COMMON USUAL NAME:
Embolectomy Catheter
CLASSIFICATION:
Class II
CLASSIFICATION NUMBER:
74 DXE
DEVICE DESCRIPTION:
The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.
The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.
The catheter, with the balloon deflated, is advanced into the vessel beyond the clot. The balloon is inflated with sterile solution. The catheter is withdrawn pulling the embolism with it, thus removing it from the artery.
The materials used on the Vaso-Safe Arterial Embolectomy Catheters have been used for years on other models of Ideas for Medicine, Inc. catheters except the suture, which has been certified to USP grade. Other catheter materials have been certified to meet the requirements of USP Class VI tests. Every lot is supplied sterile and nonpyrogenic.
SUBSTANTIAL EQUIVALENCE:
The intended use of these devices is to remove arterial emboli and thrombi. This use is identical to the Fogarty Embolectorny Catheter. The Robicsek Angiography Embolectomy Catheters are for arterial emboli and thrombi removal but provide the ability to irrigate concurrent with removal.