Cleared Traditional

K914001 - TARGET THERAPEUTICS RADIOPAQUE STYLET

K914001 is an FDA 510(k) clearance for TARGET THERAPEUTICS RADIOPAQUE STYLET, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K914001 · Target Therapeutics · Cardiovascular device
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Nov 1991
Decision
77d
Days
Class 2
Risk

K914001 is an FDA 510(k) clearance for the TARGET THERAPEUTICS RADIOPAQUE STYLET. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Target Therapeutics devices

FDA 510(k) Submission Details - K914001

510(k) Number K914001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date November 22, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRB Stylet, Catheter

All 20
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K914001.
ENSTYLET MODELS EC0010, EC0020
K993376 · Endocardial Solutions, Inc. · Jan 2000
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · Spectranetics Corp. · Oct 1999
LEAD STYLET
K905674 · Cardiac Pacemakers, Inc. · Jan 1991
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988
STIFF STYLETS
K802076 · Cardiac Pacemakers, Inc. · Sep 1980