Cleared Traditional

K851140 - TELEFLEX MEDICAL INTRODUCER NEEDLE

K851140 is the FDA 510(k) clearance for TELEFLEX MEDICAL INTRODUCER NEEDLE by Teleflexmedical, Inc.. It is a Class 1 Cardiovascular device (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

Submission Details

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.

Device Classification

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 32
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851140.
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K820258 · Howmedica Corp. · Mar 1982