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harbor s e a -port surgical accessory kit
Harbor Medical Devices
Summary: The Harbor S E A -Port Surgical Accessory Kit is a Class 2 medical device used primarily in embolization procedures. It was FDA-cleared via the 510k pathway in 1988. Current evidence includes five studies, though none specifically address this device.
FDA Clearance Information
Pathway
510K
Number
K882657 ↗
Decision Date
December 13, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Harbor S E A -Port Surgical Accessory Kit was cleared by the FDA through the 510k pathway on December 13, 1988. It is manufactured by Harbor Medical Devices and is classified as a Class 2 device.
What It Is
The Harbor S E A -Port Surgical Accessory Kit is designed for use in embolization procedures, providing necessary tools for clinicians to perform these interventions. It is intended to assist in the delivery and deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and surgical settings where embolization is required, such as in the treatment of aneurysms or vascular malformations. It aids in precise coil placement and deployment.
Evidence Summary
The available literature includes five studies, none of which directly evaluate the Harbor S E A -Port Surgical Accessory Kit. These studies range from unknown years and cover various clinical trials related to cancer treatments.
Reported Outcomes
Published studies report no direct outcomes related to the Harbor S E A -Port Surgical Accessory Kit. The linked studies focus on cancer treatments and do not provide specific efficacy data for this device.
Safety Profile
Reported complications include no specific safety data for the Harbor S E A -Port Surgical Accessory Kit, as the linked studies do not address this device. General safety in embolization procedures should be considered.
Evidence Limitations
The primary limitation is the lack of direct clinical studies evaluating the Harbor S E A -Port Surgical Accessory Kit. Further research is needed to assess its specific efficacy and safety in embolization procedures.
Frequently Asked Questions
What are the clinical indications for Harbor S E A -Port Surgical Accessory Kit?
The device is indicated for use in embolization procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
No specific outcomes for this device are reported in the available studies.
What complications have been reported?
No specific complications for this device are reported in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.