# Heartport, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 24 (1996–2000): 24 510(k) clearances
- Product codes: DWF (11), DXC (5), DRC (2), GEI (1), DWZ (1), GCJ (1), OCL (1), DYB (1), DSS (1)
- Predicates its devices cite: 12 (7 its own); citations of its devices by later devices: 22 (7 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dlp, Inc.: 2 (https://510kreport.com/company/dlp)
- American Edwards Laboratories: 1 (https://510kreport.com/company/american-edwards-laboratories)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)
- Electro-Catheter Corp.: 1 (https://510kreport.com/company/electro-catheter)

## Firms that cite its devices most
- AtriCure, Inc.: 3 (https://510kreport.com/company/atricure)
- Edwards Lifesciences, LLC: 3 (https://510kreport.com/company/edwards-lifesciences)
- Cardio Life Research, S.A.: 2 (https://510kreport.com/company/cardio-life-research)
- Medtronic Perfusion Systems: 2 (https://510kreport.com/company/medtronic-perfusion-systems)
- Coaxia, Inc.: 1 (https://510kreport.com/company/coaxia)
- Afx, Inc.: 1 (https://510kreport.com/company/afx)
- Cryogen, Inc.: 1 (https://510kreport.com/company/cryogen)
- Guidant Corporation, Cardiac Surgery: 1 (https://510kreport.com/company/guidant-cardiac-surgery)

## Its most-cited devices
- K970496: Heartport Maze System: Cryoprobe Set (1997), cited by 6
- K974175: Heartport Endoaortic Clamp Catheter (1997), cited by 3
- K955132: Heartport Endoaortic Clamp (1996), cited by 3
- K962510: Heartport Endoaortic Clamp (1996), cited by 2
- K961270: Heartport Endosinus Catheter (1996), cited by 2
- K962366: Heartport Cable Bulldog Clamp (1996), cited by 1

## Recent decisions
- K994243: Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip (May 5, 2000)
- K981995: Quickdraw Venous Cannula (Apr 20, 1999)
- K990772: Directflow Arterial Cannula (Mar 23, 1999)
- K981009: Heartport Endopulmonary Vent Catheter (Sep 4, 1998)
- K974736: Heartport Direct Aortic Return Cannula with Introducer (Jul 15, 1998)
- K974175: Heartport Endoaortic Clamp Catheter (Dec 16, 1997)
- K972570: Heartport Introducer Sheath (Oct 1, 1997)
- K971291: Heartport Endoarterial Return Cannula (Jun 17, 1997)

Source page: https://510kreport.com/company/heartport