# Sentreheart, Inc.

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 6 (2006–2015): 6 510(k) clearances
- Names in FDA's records: Sentreheart, Inc. (5); Sentreheart (1)
- Product codes: GAT (4), DQX (1), DQY (1)
- Predicates its devices cite: 15 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Genzyme Biosurgery: 2 (https://510kreport.com/company/genzyme-biosurgery)
- Lake Region Mfg., Inc.: 1 (https://510kreport.com/company/lake-region-mfg)
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)
- Radius Medical Technologies, Inc.: 1 (https://510kreport.com/company/radius-medical-technologies)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Epitek, Inc.: 1 (https://510kreport.com/company/epitek)

## Its most-cited devices
- K060721: Lariat Loop Applicator (2006), cited by 2
- K090385: Lariat II Suture Delivery Device (2009), cited by 1
- K142241: LARIAT sulture Delivery Device (2014), cited by 1

## Recent decisions
- K153096: LARIAT RS Suture Delivery Device (Nov 25, 2015)
- K142241: LARIAT sulture Delivery Device (Sep 12, 2014)
- K090385: Lariat II Suture Delivery Device (May 6, 2009)
- K080364: Findrwirz Guide Wire System (Aug 11, 2008)
- K070126: Occlusion Balloon Catheter (Feb 8, 2008)
- K060721: Lariat Loop Applicator (Jun 2, 2006)

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