# Irvine Biomedical, A St. Jude Medical Company

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (2014–2022): 2 510(k) clearances
- Names in FDA's records: Irvine Biomedical, A St. Jude Medical Company (1); Irvine Biomedical, Inc., A St. Jude Medical Company (1)
- Product codes: OBJ (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Abbott Medical: 3 (https://510kreport.com/company/abbott-medical)
- Innovative Health, LLC: 2 (https://510kreport.com/company/innovative-health)
- Stryker Sustainability Solutions: 2 (https://510kreport.com/company/stryker-sustainability-solutions)
- Sterilmed, Inc.: 1 (https://510kreport.com/company/sterilmed)
- Surgical Instrument Services and Savings, Inc.: 1 (https://510kreport.com/company/surgical-instrument-services-and-savings)

## Its most-cited devices
- K133853: Viewflex Xtra Ice Catheter (2014), cited by 8
- K223077: ViewFlex Xtra ICE Catheter (2022), cited by 2

## Recent decisions
- K223077: ViewFlex Xtra ICE Catheter (Dec 7, 2022)
- K133853: Viewflex Xtra Ice Catheter (May 19, 2014)

Source page: https://510kreport.com/company/irvine-biomedical-a-st-jude-medical