# K062569: Safeguard 24 CM Pressure Assisted Dressing

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Feb 14, 2007 after 167 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K033300: Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers, Ortho-Clinical Diagnostics, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K021182: Radiolucent Colles Compression/Distraction Bar, Biomet, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122405: Air-Band Radial Compression Device (2012), 2 descendants of its own
- K191827: Sunmed Disposable Angio-Closure Pads (2020), 0 descendants of its own
- K132293: Syvek Radial Band (2014), 0 descendants of its own
- K131411: Coseal (2013), 0 descendants of its own

## Indications for use
The indications for use for the Safeguard 24 cm pressure assisted device are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures with an ACT of 140 seconds or less, using a 6 French and smaller sheath size.

Source page: https://510kreport.com/device/K062569
Methodology: https://510kreport.com/methodology