Cleared Traditional

K002627 - ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

K002627 is an FDA 510(k) clearance for ATRIUM MEDICAL CORPORATION CLEARWAY PTF..., 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 246-day FDA review.

K002627 · Atrium Medical Corp. · Cardiovascular device
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Apr 2001
Decision
246d
Days
Class 2
Risk

K002627 is an FDA 510(k) clearance for the ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 246 days - an extended review 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: 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K002627

510(k) Number K002627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date April 26, 2001
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
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 59
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K002627.
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · LeMaitre Vascular, Inc. · Jan 2003
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · Atrium Medical Corp. · May 2002
MULTI-SNARE SET
K011783 · Pfm Produkte Fur Die Medizin AG · Jan 2002
LEMAITRE IRRIGATION CATHETER
K992933 · Vascutech, Inc. · Mar 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · Vascutech, Inc. · Mar 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · Vascutech, Inc. · Feb 2000