Cleared Traditional

PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET

K860307 · Teleflex, Inc. · Cardiovascular
May 1986
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K860307 is an FDA 510(k) clearance for the PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Teleflex, Inc. (Jeffrey, US). The FDA issued a Cleared decision on May 20, 1986, 112 days after receiving the submission on January 28, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K860307 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1986
Decision Date May 20, 1986
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340