510(k) K140110

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET by Teleflex, Inc. — Product Code BSO

K140110 is an FDA 510(k) premarket notification submitted by Teleflex, Inc. for the device "FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET". The FDA issued a decision of Substantially Equivalent on March 27, 2015. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Teleflex, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2015
Date Received
January 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type