LeMaitre Embolectomy Catheter 1601-78

GUDID 00840663100538

7F 80 cm LeMaitre Embolectomy Catheter

LEMAITRE VASCULAR, INC.

Thrombectomy balloon catheter

• Primary Device ID: 00840663100538
• NIH Device Record Key: d2988416-8fc4-46d3-aa7e-bfc97eab119f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeMaitre Embolectomy Catheter
• Version Model Number: 1601-78
• Catalog Number: 1601-78
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663100538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992368

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-30

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• 00840663100842: 7F 80CM Over-the-Wire Embolectomy Catheter, eIFU
• 00840663100835: 6F 80CM Over-the-Wire Embolectomy Catheter, eIFU
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• 00840663100798: 4F 80CM Over-the-Wire Embolectomy Catheter, eIFU
• 00840663100781: 4F 40CM Over-the-Wire Embolectomy Catheter, eIFU
• 00840663100774: 3F 80CM Over-the-Wire Embolectomy Catheter, eIFU
• 00840663100767: 3F 40CM Over-the-Wire Embolectomy Catheter, eIFU
• 00840663100750: 5F Plus 80CM Over-the-Wire Embolectomy Catheter
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• 00840663100644: 7F 80 cm LeMaitre Embolectomy Catheter, eIFU
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