Bead Block

Device, Vascular, For Promoting Embolization

BIOCOMPATIBLES UK LTD

The following data is part of a premarket notification filed by Biocompatibles Uk Ltd with the FDA for Bead Block.

Pre-market Notification Details

• Device ID: K150876
• 510k Number: K150876
• Device Name: Bead Block
• Classification: Device, Vascular, For Promoting Embolization
• Applicant: BIOCOMPATIBLES UK LTD CHAPMAN HOUSE, WEYDON LANE Farnham, Surrey, GB Gu9 8ql
• Contact: Pedro Garcia
• Correspondent: Simon Leppard; BTG International, Inc. Lakeview, Riverside Way, Watchmoor Park Camberley, Surrey, Gu15 3yl, GB
• Product Code: KRD
• Subsequent Product Code: HCG
• Subsequent Product Code: NAJ
• CFR Regulation Number: 870.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-01
• Decision Date: 2016-03-07
• Summary: summary