SuperCross Microcatheter, SuperCross FT Microcatheter, SuperCross AT Microcatheter

Catheter, Percutaneous

Vascular Solutions LLC

The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for Supercross Microcatheter, Supercross Ft Microcatheter, Supercross At Microcatheter.

Pre-market Notification Details

• Device ID: K210647
• 510k Number: K210647
• Device Name: SuperCross Microcatheter, SuperCross FT Microcatheter, SuperCross AT Microcatheter
• Classification: Catheter, Percutaneous
• Applicant: Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369
• Contact: Steph Pahl
• Correspondent: Steph Pahl; Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-03
• Decision Date: 2021-04-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20841156107472	K210647	000
20841156107465	K210647	000
20841156107458	K210647	000
20841156107441	K210647	000
20841156107434	K210647	000
20841156107427	K210647	000