HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH

Introducer, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Heartspan Fixed Curve Braided Transseptal Sheath.

Pre-market Notification Details

• Device ID: K132720
• 510k Number: K132720
• Device Name: HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
• Classification: Introducer, Catheter
• Applicant: MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PAKRWAY Malvern, PA 19355
• Contact: Alina Stubbs
• Correspondent: Alina Stubbs; MERIT MEDICAL SYSTEMS, INC. 65 GREAT VALLEY PAKRWAY Malvern, PA 19355
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-30
• Decision Date: 2014-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884450504802	K132720	000
00884450504819	K132720	000
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00884450404867	K132720	000