REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

Catheter, Recording, Electrode, Reprocessed

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Electrophysiology Diagnostic Catheters.

Pre-market Notification Details

• Device ID: K121158
• 510k Number: K121158
• Device Name: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
• Classification: Catheter, Recording, Electrode, Reprocessed
• Applicant: STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369
• Contact: Jason Skramsted
• Correspondent: Jason Skramsted; STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369
• Product Code: NLH
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-16
• Decision Date: 2012-08-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888551005951	K121158	000
10888551005944	K121158	000
10888551005937	K121158	000
10888551005920	K121158	000