# K970233: Gelbfish Endo-Vac System

- Pathway: 510(k) (Traditional)
- Applicant: Gary A. Gelbfish
- Decided: Oct 8, 1997 after 260 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Endovascular suction catheter marketed by the A. S. Aloe Company: named in the summary without a submission number
- (no number) Endovascular suction catheter marketed by the Klista Company: named in the summary without a submission number

## Indications for use
The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/self-cleaning mechanism to maintain its uninterrupted function. The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the aspiration of clot from the graft. The arterial and venous anastomotic plug/clot and pathology must still be addressed by standard Fogarty and/or balloon catheter procedures. Expertise in traditional pharmoco-mechanical techniques is necessary, and may be used in conjunction with the Endo-Vac System. The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the “body” of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.

Source page: https://510kreport.com/device/K970233
Methodology: https://510kreport.com/methodology