510(k) K871998

GROSHONG CV CATHETER REPAIR KIT by Catheter Technology Corp. — Product Code LJS

K871998 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "GROSHONG CV CATHETER REPAIR KIT". The FDA issued a decision of Substantially Equivalent on June 24, 1987. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1987
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type