510(k) K926271

SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO by Schneider Intl., Ltd. — Product Code LIT

K926271 is an FDA 510(k) premarket notification submitted by Schneider Intl., Ltd. for the device "SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO". The FDA issued a decision of Substantially Equivalent on June 7, 1993. 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
June 7, 1993
Date Received
December 18, 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