Cleared Special

K003938 - TRAK BACK II

K003938 is an FDA 510(k) clearance for TRAK BACK II, manufactured by Jomed, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 29-day FDA review.

K003938 · Jomed, Inc. · Cardiovascular device
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Jan 2001
Decision
29d
Days
Class 2
Risk

K003938 is an FDA 510(k) clearance for the TRAK BACK II. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Jomed, Inc. (Rockville, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jomed, Inc. devices

FDA 510(k) Submission Details - K003938

510(k) Number K003938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2000
Decision Date January 18, 2001
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 396
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K003938.
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories · May 2001
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K010707 · Boston Scientific, Target · Mar 2001
COOK PRESSURE MONITORING CATHETER
K002254 · Cook, Inc. · Mar 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · AngioDynamics, Inc. · Jan 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · NuMED, Inc. · Jan 2001
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · AngioDynamics, Inc. · Oct 2000