# K981624: Flo-Thru

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Aug 4, 1998 after 89 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 3 (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. The FDA summary names its predicate without a number.
- (no number) BVI Flo-Rester vessel occluder: named in the summary without a submission number
- (no number) CTS MIDCAB Coronary Shunt (CTS FloCoil Shunt): named in the summary without a submission number
- (no number) AnastaFLO Intravascular Shunt: named in the summary without a submission number
- (no number) DLP Intravascular Arteriotomy Cannula: named in the summary without a submission number
- (no number) Rivetti-Levinson Intraluminal Shunt: named in the summary without a submission number
- (no number) Chase Blood Vessel Shunt: named in the summary without a submission number

## Recalls of this device
- Feb 22, 2024 · Class II · Z-1523-2024: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe 
- Dec 6, 2023 · Class II · Z-0663-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for
- Apr 1, 2022 · Class II · Z-1019-2022: There is a potential for foreign matter.

## Indications for use
The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

Source page: https://510kreport.com/device/K981624
Methodology: https://510kreport.com/methodology