# Cardima, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 12 (1993–2006): 12 510(k) clearances
- Product codes: DRF (5), DQY (3), OCL (2), KRA (1), DQX (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 15 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Cardiorhythm: 1 (https://510kreport.com/company/medtronic-cardiorhythm)
- Medtronics Interventional Vascular: 1 (https://510kreport.com/company/medtronics-interventional-vascular)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Firms that cite its devices most
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Guidant Corp.: 2 (https://510kreport.com/company/guidant)
- Biocardia, Inc.: 2 (https://510kreport.com/company/biocardia)
- Epicor Medical, Inc.: 1 (https://510kreport.com/company/epicor-medical)
- Omnisonics Medical Technologies: 1 (https://510kreport.com/company/omnisonics-medical-technologies)
- Acumen Medical, Inc.: 1 (https://510kreport.com/company/acumen-medical)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K974683: Naviport Deflectable Tip Guiding Catheter (1999), cited by 6
- K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter (1998), cited by 5
- K022008: Cardima Ablation System (2003), cited by 2
- K970853: Pathfinder 3MM Mapping Microcatheter (01-082001) (1997), cited by 1
- K955802: Pathfinder (1997), cited by 1

## Recent decisions
- K060715: Modification to: Cardima Ablation System (May 15, 2006)
- K022008: Cardima Ablation System (Jan 29, 2003)
- K974683: Naviport Deflectable Tip Guiding Catheter (Jun 22, 1999)
- K972803: Tracer O-T-W Mapping Device (May 11, 1999)
- K982835: Electrode Switchbox, Model 11-081002 (Oct 29, 1998)
- K971975: Cardima Pathfinder 1.5F Mapping Microcatheter (Jul 1, 1998)
- K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter (Jun 26, 1998)
- K970853: Pathfinder 3MM Mapping Microcatheter (01-082001) (Nov 4, 1997)

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