SafeSept Transseptal Guidewire

Trocar

Pressure Products Medical Device Manufacturing LLC

The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc with the FDA for Safesept Transseptal Guidewire.

Pre-market Notification Details

• Device ID: K170671
• 510k Number: K170671
• Device Name: SafeSept Transseptal Guidewire
• Classification: Trocar
• Applicant: Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070
• Contact: Andrew Armour
• Correspondent: Andrew Armour; Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070
• Product Code: DRC
• CFR Regulation Number: 870.1390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-06
• Decision Date: 2017-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30858769006105	K170671	000