# Strato Medical Corp.

- Location (FDA's records): Beverly, MA
- FDA decisions: 46 (1983–1995): 45 510(k) clearances and 1 original PMA approval
- Product codes: LJT (27), LJS (8), FRN (6), FPA (4), LKN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Horizon Medical Products, Inc.: 2 (https://510kreport.com/company/horizon-medical-products)
- Rita Medical Systems: 1 (https://510kreport.com/company/rita-medical-systems)
- Stealth Therapeutics, Incorporated: 1 (https://510kreport.com/company/stealth-therapeutics)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)

## Its most-cited devices
- K934518: Strato Medical Infuse-a-Port/Infuse-a-Kit Periport Peripheral Access System (1995), cited by 1
- K905852: Strato Plast Port Intro KT (10 FR)LPS 7013/Modified (1991), cited by 1
- K905841: Strato Port Introducer KT (12 FR) LPS 5200/Modified (1991), cited by 1
- K924851: Strato Medical Single Lumen Valved Catheter (1993), cited by 1
- K921674: Lifeport Infusion Set and Infusion Set W/ Y Site (1992), cited by 1

## Recent decisions
- K945956: Strato Medical Infuse-a-Cath Triple Lumen Silicone Catheter Systems (Jun 6, 1995)
- K946250: Strato Medical Infuse-a-Cath, Triple Lumen Polyurethane, Central Vnous Catheter Systems (May 2, 1995)
- K942848: Strato Medical  Lifeport LPS 7515 (Feb 1, 1995)
- K934518: Strato Medical Infuse-a-Port/Infuse-a-Kit Periport Peripheral Access System (Jan 27, 1995)
- K932509: Strato Medical Infuse-a-Port/Snap-Lock Macroprort (Jan 7, 1994)
- K933884: Strato Medical Lifeport LPS 7255 Low Profile Dual Lumen Vascular Access System (Dec 30, 1993)
- K924851: Strato Medical Single Lumen Valved Catheter (Dec 13, 1993)
- K924677: Strato Medical Infuse-a-Cath Polyure Cen Ven Cath (Jul 30, 1993)

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