Cleared Traditional

K922912 - SEEKER LITE - 10

K922912 is the FDA 510(k) clearance for SEEKER LITE - 10 by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K922912 · Target Therapeutics · Cardiovascular device
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Nov 1992
Decision
153d
Days
Class 2
Risk

K922912 is an FDA 510(k) clearance for the SEEKER LITE - 10. 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 November 17, 1992 after a review of 153 days - an extended review cycle.

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 K922912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date November 17, 1992
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
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 K922912.
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1992
TAPER GUIDEWIRES
K924987 · Target Therapeutics · Dec 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202 · Terumo Medical Corp. · Nov 1992
CORDIS STEERABLE GUIDEWIRE
K923134 · Cordis Corp. · Oct 1992
ROADRUNNER RLTF GUIDE WIRE
K920824 · Cook, Inc. · Oct 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240 · Baxter Healthcare Corp · Sep 1992