WHOLEY GUIDE WIRE SYSTEM

Wire, Guide, Catheter

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Wholey Guide Wire System.

Pre-market Notification Details

• Device ID: K120863
• 510k Number: K120863
• Device Name: WHOLEY GUIDE WIRE SYSTEM
• Classification: Wire, Guide, Catheter
• Applicant: Covidien LLC 3033 Campus Drive Plymouth, MN 55441
• Contact: David Rbertson
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-03-22
• Decision Date: 2012-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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