510(k) K872790

PERFUSION CATHETER by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DQT

K872790 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "PERFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on September 15, 1987. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1987
Date Received
July 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Occluder, Catheter Tip
Device Class
Class II
Regulation Number
870.1370
Review Panel
CV
Submission Type