# K970027: Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005

- Pathway: 510(k) (Traditional)
- Applicant: Rmds, Inc.
- Decided: Aug 8, 1997 after 217 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FAVC-M: Femoral Artery Vascular Clamp-Mobile is used to provide pressure hemostasis after the removal of arterial catheters following femoral catheterization procedures. The FAVC-M: Femoral Artery Vascular Clamp-Mobile is positioned prior to removal of femoral catheters and apply controlled pressure to the puncture site until hemostasis is complete.

Source page: https://510kreport.com/device/K970027
Methodology: https://510kreport.com/methodology