# Great Batch Medical

- Location (FDA's records): Plymouth, MN
- FDA decisions: 11 (2009–2018): 10 510(k) clearances and 1 original PMA approval
- Product codes: DYB (7), DRC (2), DTB (1), DRA (1)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Enpath Medical, Inc.: 3 (https://510kreport.com/company/enpath-medical)
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Medtronic Cryocath, LP: 1 (https://510kreport.com/company/medtronic-cryocath)
- Thomas Medical Products, Inc.: 1 (https://510kreport.com/company/thomas-medical-products)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Firms that cite its devices most
- Teleflex, Inc.: 1 (https://510kreport.com/company/teleflex)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K093023: Ptfe Peelable Introducer (2009), cited by 1
- K102540: Ptfe Portable Introducer (2010), cited by 1
- K110051: Radialsource Transradial Access Introducer Kit (2012), cited by 1

## Recent decisions
- K181855: RadialSeal Introducer Kit (Jul 26, 2018)
- P130012: Myopore Sutureless Myocardial Pacing Lead (Apr 30, 2015)
- K130559: Mobicath BI-Directional Guiding Sheath (May 24, 2013)
- K122832: Mobicath Transseptal Needle (Dec 19, 2012)
- K112541: Z Flex-270TM Steerable Sheath (Feb 7, 2012)
- K110051: Radialsource Transradial Access Introducer Kit (Feb 2, 2012)
- K111644: Mobicath Transseptal Needle (Oct 3, 2011)
- K101784: Mobicath BI-Directional Guiding Sheath Model 1000182-XXX (Nov 26, 2010)

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