AMPLATZ GOOSE NECK™

Basic Information

• Brand Name: AMPLATZ GOOSE NECK™
• Primary DI: 00763000225377
• Version / Model: SK200
• Company Name: EV3, INC
• Labeler DUNS: 117446916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-16
• Public Version: 2
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 65b26896-34db-4f5c-8b79-ea1a1354377b

Device Description

SNARE SK200 MICRO SNARE V01

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17927	Intravascular extraction catheter-snare	A flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000225377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970668	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Snare Length 175 Centimeter
Catheter Working Length	150.0	Centimeter
Catheter Inner Diameter	0.53	Millimeter
Device Size Text, specify			Loop Diameter 2 Millimeter
Device Size Text, specify			Wire Diameter 0.46 Millimeter
Device Size Text, specify			2.3-3.0 FR

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Store away from sunlight at room temperature in a dry place.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight