Cleared Traditional

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER

K861951 · Teleflex, Inc. · Cardiovascular
Jun 1986
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K861951 is an FDA 510(k) clearance for the MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Teleflex, Inc. (Jeffrey, US). The FDA issued a Cleared decision on June 19, 1986, 30 days after receiving the submission on May 20, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K861951 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1986
Decision Date June 19, 1986
Days to Decision 30 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