510(k) K980360

SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES by Scimed Life Systems, Inc. — Product Code DQX

K980360 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on April 29, 1998. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scimed Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1998
Date Received
January 29, 1998
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