Cleared Traditional

K992940 - LEMAITRE BALLOON CATHETER WITH IRRIGATION

K992940 is an FDA 510(k) clearance for LEMAITRE BALLOON CATHETER WITH IRRIGATION, manufactured by Vascutech, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K992940 · Vascutech, Inc. · Cardiovascular device
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Feb 2000
Decision
175d
Days
Class 2
Risk

K992940 is an FDA 510(k) clearance for the LEMAITRE BALLOON CATHETER WITH IRRIGATION. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Vascutech, Inc. (Burlington, US). The FDA issued a Cleared decision on February 22, 2000 after a review of 175 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 Vascutech, Inc. devices

FDA 510(k) Submission Details - K992940

510(k) Number K992940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1999
Decision Date February 22, 2000
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 58
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K992940.
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · Atrium Medical Corp. · Apr 2001
LEMAITRE IRRIGATION CATHETER
K992933 · Vascutech, Inc. · Mar 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · Vascutech, Inc. · Mar 2000
LEMAITRE EMBOLECTOMY CATHETER
K992368 · Vascutech, Inc. · Dec 1999
BIOSENSORS EMBOLECTOMY CATHETER
K973477 · Sunscope Intl., Inc. · Sep 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998