Turbo Tandem™

Basic Information

• Brand Name: Turbo Tandem™
• Primary DI: M2044821100
• Version / Model: 482-110
• Catalog Number: 482-110
• Company Name: Spectranetics Corporation
• Labeler DUNS: 151047370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-26
• Public Version: 5
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: b94321ee-8b38-4e58-b8e2-df26602ca4bc
• Distribution End Date: 2019-02-06

Device Description

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy 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: 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43229	Atherectomy laser system beam guide-catheter, peripheral	A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M2044821100	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112032	000
K140775	000

Device Sizes

Type	Value	Unit	Text
Length	110	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit