Cleared Traditional

K820646 - ATRAC TM MULTIPURPOSE BALLOON CATHETER

K820646 is an FDA 510(k) clearance for ATRAC TM MULTIPURPOSE BALLOON CATHETER, manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K820646 · Atrium Medical Corp. · Cardiovascular device
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Mar 1982
Decision
16d
Days
Class 2
Risk

K820646 is an FDA 510(k) clearance for the ATRAC TM MULTIPURPOSE BALLOON CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K820646

510(k) Number K820646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1982
Decision Date March 25, 1982
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 36
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K820646.
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · Uresil Corp. · Jan 1987
ARTERIAL EMBOLECTOMY CATHETER
K840198 · Shiley, Inc. · Aug 1984
SHILEY MULTIPRO CATHETER
K832044 · Shiley, Inc. · Sep 1983
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K812640 · Uresil Corp. · Oct 1981
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838 · Shiley, Inc. · Jun 1979
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · Shiley, Inc. · May 1978