# K053300: Syvekexcel

- Pathway: 510(k) (Traditional)
- Applicant: Marine Polymer Technologies, Inc.
- Decided: Mar 28, 2006 after 123 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
Longest line of descent: 6 generations back to K953781 (1995). 25 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984177: Modification to Skvekpatch, Marine Polymer Technologies, Inc. (1998) Summary page 1.
- K040615: Compressar Supercomfort Disc and Strongarm Supercomfort System, Advanced Vascular Dynamics (2004) Summary page 1.
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003) Summary page 1.
- K050146: Vascular Solutions D-Stat Clamp Accessory, Vascular Solutions, Inc. (2005)
- K973132: EZ Hold 1 LBS., EZ Hold 2 LBS, Tz Medical, Inc. (1998) Summary page 1.
- K024107: Femostop Femoral Compression System, Radi Medical Systems AB (2002) Summary page 1.
- K964663: Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F and PAD6EK-FX, Rmds, Inc. (1997) Summary page 1.
- K021062: Chito-Seal, Abbott Vascular, Inc. (2002) Summary page 1.

## Most influential descendants
- K061219: D-Stat Dry Hemostatic Bandage (2006), 13 descendants of its own
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K072890: Stasilon FR (2007), 5 descendants of its own
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own

## Indications for use
Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

Source page: https://510kreport.com/device/K053300
Methodology: https://510kreport.com/methodology