# Embol-X, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 4 (1999–2003): 4 510(k) clearances
- Product codes: DWF (1), DYB (1), DTM (1), DXC (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Percu Surge, Inc.: 1 (https://510kreport.com/company/percu-surge)
- Bentley Laboratories, Inc.: 1 (https://510kreport.com/company/bentley-laboratories)
- Heartport, Inc.: 1 (https://510kreport.com/company/heartport)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)
- Dlp, Inc.: 1 (https://510kreport.com/company/dlp)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)

## Firms that cite its devices most
- Cardiogard Medical, Ltd.: 2 (https://510kreport.com/company/cardiogard-medical)
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000 (2003), cited by 2
- K020693: Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101 (2002), cited by 1
- K002973: Embol-X Introducer, Model CF00200 (2001), cited by 1

## Recent decisions
- K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000 (Feb 14, 2003)
- K020693: Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101 (Sep 5, 2002)
- K002973: Embol-X Introducer, Model CF00200 (Apr 26, 2001)
- K980631: Embol-X Aortic Occlusion and Cardioplegia Cannula (Feb 2, 1999)

Source page: https://510kreport.com/company/embol-x