Turbo Tandem™ 472-110

GUDID M2044721100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: M2044721100
• NIH Device Record Key: 8616dbd1-7518-4bb8-ac9e-7c5111eb58d8
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Turbo Tandem™
• Version Model Number: 472-110
• Catalog Number: 472-110
• Company DUNS: 151047370
• Company Name: Spectranetics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com

Device Dimensions

• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2044721100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K094036

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

[M2044721100]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-26
• Device Publish Date: 2014-08-19

On-Brand Devices [Turbo Tandem™]

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• M204472110AA0: Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
• M2044821100: Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
• M2044721100: Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter