Cleared Traditional

K012225 - ATTAIN 6215 VENOGRAM BALLOON CATHETER

K012225 is an FDA 510(k) clearance for ATTAIN 6215 VENOGRAM BALLOON CATHETER, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K012225 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
43d
Days
Class 2
Risk

K012225 is an FDA 510(k) clearance for the ATTAIN 6215 VENOGRAM BALLOON CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K012225

510(k) Number K012225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 28, 2001
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K012225.
Swan Ganz Catheters
K160084 · Edwards Lifesciences, LLC · May 2016
OCCLUSION BALLOON CATHETER, MODEL VENOS
K081052 · Oscor, Inc. · Jun 2008
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · Transonic Systems, Inc. · Mar 2002
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp · Jul 2000
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
K993245 · Alba Critical Care, Ltd. · Oct 1999
HARMAC THERMODILUTION CATHETER
K963336 · Harmac Medical Products, Inc. · Aug 1997