# K964284: Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 6, 1997 after 70 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912035 (1995). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912035: Stainless Steel Green Vena Cava Filt W/12F Intr SY, Boston Scientific Corp (1995). Our OCR of the scanned summary read K912038, FDA’s number for Dash Medical Gloves (Safehealth Labs). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer…”.

## Most influential descendants
- K081410: Option Vena Cava Filter (2009), 6 descendants of its own
- K133243: Option Elite Vena Cava Filter System (2013), 2 descendants of its own
- K120402: Crux Vena Cava Filter System (2012), 2 descendants of its own
- K143405: Option (TM) ELITE Vena Cava Filter 100cm System (2015), 1 descendant of its own
- K122585: Crux Vena Cava Filter System (2013), 1 descendant of its own

## Recalls of this device
- Oct 6, 2006 · Not classified · Z-0794-2007: One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
- Dec 2, 2005 · Not classified · Z-0280-06: There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 
- Aug 5, 2005 · Not classified · Z-0299-06: Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of 

## Indications for use
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the vena cava in the following situations: Venous thrombosis or pulmonary thromboembolism when anticoagulants are contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism. Failure of anticoagulant therapy in thromboembolic disease. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Source page: https://510kreport.com/device/K964284
Methodology: https://510kreport.com/methodology