510(k) K862550

OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE by Meadox Surgimed, Inc. — Product Code LIT

K862550 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1986
Date Received
July 3, 1986
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