510(k) K210235

Verrata PLUS Pressure Guide Wire by Volcano Corporation — Product Code DQX

K210235 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "Verrata PLUS Pressure Guide Wire". The FDA issued a decision of Substantially Equivalent on April 15, 2021. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Volcano Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2021
Date Received
January 28, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type