HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

Wire, Guide, Catheter

ABBOTT VASCULAR-CARDIAC THERAPIES

The following data is part of a premarket notification filed by Abbott Vascular-cardiac Therapies with the FDA for Hi-torque Balance Middleweight Elite.

Pre-market Notification Details

• Device ID: K103101
• 510k Number: K103101
• Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• Classification: Wire, Guide, Catheter
• Applicant: ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. Temecula, CA 92591
• Contact: Kay Setzer
• Correspondent: Kay Setzer; ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. Temecula, CA 92591
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-20
• Decision Date: 2011-02-10
• Summary: summary