REPROCESSED SEALED 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 Sealed Electrophysiology Diagnostic Catheters.

Pre-market Notification Details

• Device ID: K012678
• 510k Number: K012678
• Device Name: REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
• Classification: Catheter, Recording, Electrode, Reprocessed
• Applicant: STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369
• Contact: Patick Fleischhacker
• Correspondent: Patick Fleischhacker; 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: 2001-08-14
• Decision Date: 2002-08-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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