STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER

Catheter, Recording, Electrode, Reprocessed

STERILMED, INC.

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

Pre-market Notification Details

• Device ID: K043513
• 510k Number: K043513
• Device Name: STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Classification: Catheter, Recording, Electrode, Reprocessed
• Applicant: STERILMED, INC. 1140O 73RD AVE. NORTH Minneapolis, MN 55369
• Contact: Bruce R Lester
• Correspondent: Bruce R Lester; STERILMED, INC. 1140O 73RD AVE. NORTH Minneapolis, 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: 2004-12-20
• Decision Date: 2005-03-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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