Cleared Traditional

K034050 - CORDIS OPTEASE VENA CAVA FILTER

Also marketed or referenced as:
RETRIEVABLE CATHETER, MODEL 466-C220F

K034050 is an FDA 510(k) clearance for CORDIS OPTEASE VENA CAVA FILTER, manufactured by Cordis Corporation. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K034050 · Cordis Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
83d
Days
Class 2
Risk

K034050 is an FDA 510(k) clearance for the CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Cordis Corporation (Warren, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corporation devices

FDA 510(k) Submission Details - K034050

510(k) Number K034050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date March 22, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTK Device Classification - Class 2, Special Controls

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 - DTK Filter, Intravascular, Cardiovascular

All 44
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K034050.
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · Bard Peripheral Vascular, Inc. · Nov 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · C.R. Bard, Inc. · Aug 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · Cook, Inc. · May 2005
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · Cook, Inc. · Oct 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · C.R. Bard, Inc. · Jul 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · C.R. Bard, Inc. · Nov 2002