EMBOL-X Intra-Aortic Filter with Duraflo Coating

Basic Information

• Brand Name: EMBOL-X Intra-Aortic Filter with Duraflo Coating
• Primary DI: 00690103166330
• Version / Model: EXXSD
• Catalog Number: EXXSD
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2019-04-09
• Public Version Status: Update
• Public Device Record Key: 0f472e32-e338-46bb-85e2-ed2b52524d29

Device Description

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING

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
DTM	Filter, blood, cardiopulmonary bypass, arterial line	Cardiovascular	870.4260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44841	Embolic protection filtering guidewire	A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103166330	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062429	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			ID 22-26 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store sterile packaged device in a cool, dry, dark place until ready for use.