510(k) K871377

NAMIC COURNAND STYLE INTRODUCER NEEDLE by North American Instrument Corp. — Product Code DRC

K871377 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "NAMIC COURNAND STYLE INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on May 7, 1987. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1987
Date Received
April 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type