# K992368: Lemaitre Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascutech, Inc.
- Decided: Dec 9, 1999 after 147 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 30, 2022 · Class II · Z-0228-2023: Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the
- Oct 21, 2015 · Class II · Z-0386-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0388-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0389-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0387-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0390-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Feb 7, 2005 · Not classified · Z-0558-05: Product sterility maybe compromised due to defective packaging
- Feb 7, 2005 · Not classified · Z-0557-05: Product sterility maybe compromised due to defective packaging
- Feb 7, 2005 · Not classified · Z-0560-05: Product sterility maybe compromised due to defective packaging

## Indications for use
The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.

Source page: https://510kreport.com/device/K992368
Methodology: https://510kreport.com/methodology