SWIFTGUARDTM 8FR BALLOON GUIDE CATHETER

GUDID 00763000491772

BALLOON GUIDE CATHETER 8F-087-85 CM V01

Micro Therapeutics, Inc.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00763000491772
• NIH Device Record Key: 3c5ba25a-6bc0-4b6f-bf31-dda629ea0b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWIFTGUARDTM 8FR BALLOON GUIDE CATHETER
• Version Model Number: 8F-087-85CM
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000491772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203840

FDA Product Code

• DQY: Catheter, percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-23
• Device Publish Date: 2021-04-15

On-Brand Devices [SWIFTGUARDTM 8FR BALLOON GUIDE CATHETER]

• 00763000491789: BALLOON GUIDE CATHETER 8F-087-95 CM V01
• 00763000491772: BALLOON GUIDE CATHETER 8F-087-85 CM V01