510(k) K895179

ACCESSOR PERIPHERAL DILATING GUIDE WIRE by Peripheral Systems Group — Product Code LIT

K895179 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "ACCESSOR PERIPHERAL DILATING GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on February 28, 1990. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Peripheral Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1990
Date Received
August 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type