Cleared Traditional

K914067 - RETRIEVAL DEVICE

K914067 is an FDA 510(k) clearance for RETRIEVAL DEVICE, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914067 · Target Therapeutics · Cardiovascular device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914067 is an FDA 510(k) clearance for the RETRIEVAL DEVICE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on December 10, 1991 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 870.1200 - 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

FDA 510(k) Submission Details - K914067

510(k) Number K914067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date December 10, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 408
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K914067.
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ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH
K912532 · Interventional Therapeutics Corp. · Dec 1991
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER
K914009 · Schneider Intl., Ltd. · Dec 1991
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K913871 · Boston Scientific Corp · Nov 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · Scimed Life Systems, Inc. · Nov 1991