510(k) K913297

SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH by Schneider Intl., Ltd. — Product Code LIT

K913297 is an FDA 510(k) premarket notification submitted by Schneider Intl., Ltd. for the device "SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Schneider Intl., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
July 24, 1991
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