Smart Set

Set, Administration, Intravascular

TOPSPINS, INC.

The following data is part of a premarket notification filed by Topspins, Inc. with the FDA for Smart Set.

Pre-market Notification Details

• Device ID: K151250
• 510k Number: K151250
• Device Name: Smart Set
• Classification: Set, Administration, Intravascular
• Applicant: TOPSPINS, INC. 403 RIVERVIEW DR Ann Arbor, MI 48107 -7205
• Contact: Frederick Prince
• Correspondent: Frederick Prince; TOPSPINS, INC. 403 RIVERVIEW DR Ann Arbor, MI 48107 -7205
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-12
• Decision Date: 2016-06-07