Cleared Traditional

K851140 - TELEFLEX MEDICAL INTRODUCER NEEDLE

K851140 is an FDA 510(k) clearance for TELEFLEX MEDICAL INTRODUCER NEEDLE, manufactured by Teleflexmedical, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K851140 · Teleflexmedical, Inc. · Cardiovascular device
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Jun 1985
Decision
90d
Days
Class 1
Risk

K851140 is an FDA 510(k) clearance for the TELEFLEX MEDICAL INTRODUCER NEEDLE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K851140

510(k) Number K851140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date June 19, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 53
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851140.
NAMAN POTTS COURNAND NEEDLE
K851832 · Manan Manufacturing Co., Inc. · Jul 1985
MANAN SELDINGER NEEDLE
K851833 · Manan Manufacturing Co., Inc. · Jul 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834 · Manan Manufacturing Co., Inc. · Jul 1985
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
PMA ANGIOGRAPHY TRAY
K841468 · Professional Medical Services · Jun 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984