Cleared Traditional

K950069 - DASHER-14

K950069 is the FDA 510(k) clearance for DASHER-14 by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K950069 · Target Therapeutics · Cardiovascular device
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Apr 1995
Decision
93d
Days
Class 2
Risk

K950069 is an FDA 510(k) clearance for the DASHER-14. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on April 12, 1995 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Target Therapeutics devices

Submission Details

510(k) Number K950069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1995
Decision Date April 12, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K950069.
SCIMED SCEPTOR EXCHANGE GUIDE WIRE
K950535 · Scimed Life Systems, Inc. · Apr 1995
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
K950266 · Scimed Life Systems, Inc. · Apr 1995
CORDIS STEERABLE GUIDEWIRES
K950316 · Cordis Corp. · Apr 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156 · Advanced Cardiovascular Systems, Inc. · Apr 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240 · Scimed Life Systems, Inc. · Mar 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113 · Scimed Life Systems, Inc. · Mar 1995