510(k) K931327

PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE by Peripheral Systems Group — Product Code DQX

K931327 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on July 14, 1993. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Peripheral Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1993
Date Received
March 16, 1993
Clearance Type
Traditional
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