510(k) K910221

RMI VASCULAR TOURNIQUET KIT by Research Medical, Inc. — Product Code DXC

K910221 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI VASCULAR TOURNIQUET KIT". The FDA issued a decision of Substantially Equivalent on May 16, 1991. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Research Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1991
Date Received
January 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type