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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Verrata PLUS Pressure Guide Wire, 185 cm J-tip - 10185JP; Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip - 10185P; Verrata PLUS Pressure Guide Wire, 300 cm J-tip - 10300JP; Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip - 10300P
Classification Name: WIRE, GUIDE, CATHETER
Product Code: DQX
Device Class: 2
Regulation Number: 870.1330
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K161887
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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