Socrates

Basic Information

• Brand Name: Socrates
• Primary DI: 00818075010776
• Version / Model: SC038-156-001
• Company Name: SCIENTIA VASCULAR LLC
• Labeler DUNS: 011234178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-14
• Public Version: 1
• Public Version Date: 2023-11-22
• Public Version Status: New
• Public Device Record Key: 9d606e99-d97c-46a4-959d-36b770841ddf

Device Description

Socrates Aspiration System: 156cm working length aspiration catheter

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: Yes
• MRI Safety: MR Unsafe
• 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
NRY	Catheter, Thrombus Retriever	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818075010776	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223913	000

Device Sizes

Type	Value	Unit	Text
Catheter Inner Diameter	0.038	Inch
Catheter Working Length	156	Centimeter
Outer Diameter	1.35	Millimeter
Outer Diameter	0.053	Inch
Catheter Inner Diameter	0.97	Millimeter
Catheter Gauge	4.0	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry