510(k) K925945

MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT by Scimed Life Systems, Inc. — Product Code LIT

K925945 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT". The FDA issued a decision of Substantially Equivalent on May 20, 1993. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1993
Date Received
Nov 24, 1992
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
510(k)

Source: FDA 510(k) database entry for K925945. Report a data issue: hello@regdatalab.com.