SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

Catheter, Percutaneous

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Supercross Microcatheter (130 Cm), Supercross Microcatheter (150 Cm) Model 5300, 5301.

Pre-market Notification Details

• Device ID: K101659
• 510k Number: K101659
• Device Name: SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
• Classification: Catheter, Percutaneous
• Applicant: VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369
• Contact: Matt Nienstedt
• Correspondent: Matt Nienstedt; VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT 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: 2010-06-11
• Decision Date: 2010-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M20653410	K101659	000
30841156100470	K101659	000
30841156100463	K101659	000
30841156100456	K101659	000
30841156100449	K101659	000
30841156100432	K101659	000
30841156100425	K101659	000
30841156100418	K101659	000
30841156100401	K101659	000
30841156100395	K101659	000
30841156100388	K101659	000
30841156100494	K101659	000
M20653000	K101659	000
M20653400	K101659	000
M20653090	K101659	000
M20653080	K101659	000
M20653070	K101659	000
M20653060	K101659	000
M20653050	K101659	000
M20653040	K101659	000
M20653030	K101659	000
M20653020	K101659	000
M20653010	K101659	000
30841156100371	K101659	000