510(k) K902367

OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER by Vas-Cath, Inc. — Product Code LIT

K902367 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER". The FDA issued a decision of Substantially Equivalent on December 3, 1990. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1990
Date Received
May 29, 1990
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