INQWIRE DIAGNOSTIC GUIDE WIRE

Wire, Guide, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Inqwire Diagnostic Guide Wire.

Pre-market Notification Details

• Device ID: K133230
• 510k Number: K133230
• Device Name: INQWIRE DIAGNOSTIC GUIDE WIRE
• Classification: Wire, Guide, Catheter
• Applicant: MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei
• Contact: Siobhan King
• Correspondent: Siobhan King; MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-21
• Decision Date: 2013-12-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10195327013622	K133230	000
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10884450455774	K133230	000
20884450004337	K133230	000
10884450004897	K133230	000
20884450005129	K133230	000
10884450005139	K133230	000
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10884450018351	K133230	000
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20884450025707	K133230	000
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10884450057602	K133230	000
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20884450196384	K133230	000
10884450198626	K133230	000
20884450198821	K133230	000
20884450199392	K133230	000
10884450231897	K133230	000
10884450233839	K133230	000
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20884450251465	K133230	000
20884450261143	K133230	000
10884450268145	K133230	000
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20884450029248	K133230	000
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10884450029906	K133230	000
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10884450046224	K133230	000
10884450056254	K133230	000
20884450056299	K133230	000
20884450327801	K133230	000