510(k) K960098

RMI INTERNAL MAMMARY ARTERY CANNULA by Research Medical, Inc. — Product Code DQR

K960098 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI INTERNAL MAMMARY ARTERY CANNULA". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Research Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type