# Enpath Medical, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 7 (2004–2008): 7 510(k) clearances
- Names in FDA's records: Enpath Medical, Inc. (5); Enpath Medical Incorporated (2)
- Product codes: DYB (5), DQY (2)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 13 (2 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medamicus, Inc.: 3 (https://510kreport.com/company/medamicus)
- Tfx Medical, Inc.: 1 (https://510kreport.com/company/tfx-medical)
- Thomas Medical Products, Inc.: 1 (https://510kreport.com/company/thomas-medical-products)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Firms that cite its devices most
- Great Batch Medical: 3 (https://510kreport.com/company/great-batch-medical)
- Access Scientific, Inc.: 2 (https://510kreport.com/company/access-scientific)
- Oscor, Inc.: 1 (https://510kreport.com/company/oscor)
- Biocardia, Inc.: 1 (https://510kreport.com/company/biocardia)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Guided Delivery Systems: 1 (https://510kreport.com/company/guided-delivery-systems)
- Lifetech Scientific (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/lifetech-scientific-shenzhen)
- Medcomp: 1 (https://510kreport.com/company/medcomp)

## Its most-cited devices
- K071574: Stiffer Coaxial Micro-Introducer Kit (2007), cited by 4
- K043489: Enpath Deflectable Catheter (2005), cited by 3
- K061119: Enpath Medical Steerable Sheath (2006), cited by 3
- K063182: Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX (2006), cited by 2
- K081394: Ptfe Interlock Peelable Introducers (2008), cited by 1

## Recent decisions
- K081394: Ptfe Interlock Peelable Introducers (Sep 15, 2008)
- K072248: Viapeel Peelable Introducer (Nov 9, 2007)
- K071574: Stiffer Coaxial Micro-Introducer Kit (Jul 5, 2007)
- K063182: Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX (Dec 21, 2006)
- K061119: Enpath Medical Steerable Sheath (May 18, 2006)
- K043489: Enpath Deflectable Catheter (May 19, 2005)
- K041708: Enpath Safety Introducer (Nov 30, 2004)

Source page: https://510kreport.com/company/enpath-medical