Cleared Traditional

K862117 - TRACKER INFUSION CATHETER

K862117 is an FDA 510(k) clearance for TRACKER INFUSION CATHETER, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K862117 · Target Therapeutics · Cardiovascular device
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Oct 1986
Decision
120d
Days
Class 2
Risk

K862117 is an FDA 510(k) clearance for the TRACKER INFUSION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on October 1, 1986 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 - K862117

510(k) Number K862117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date October 01, 1986
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 791
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K862117.
URESIL SUBCLAVIAN CATHETER
K863684 · Uresil Corp. · Jan 1987
VEIN VALVE CUTTER
K862724 · American Edwards Laboratories · Jan 1987
URESIL IRRIGATION CATHETER
K863564 · Uresil Corp. · Oct 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · Cordis Corp. · Sep 1986
MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS
K863322 · Quinton, Inc. · Sep 1986
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
K862056 · Arrow Intl., Inc. · Aug 1986