# Dideco S.P.A.

- Location (FDA's records): Waltham, MA
- FDA decisions: 33 (1995–2005): 33 510(k) clearances
- Names in FDA's records: Dideco S.P.A. (22); Dideco S.R.L. (6); Dideco (5)
- Product codes: DTZ (15), CAC (4), DTM (4), KFM (3), DTN (3), KDI (1), JOW (1), DRY (1), DTP (1)
- Predicates its devices cite: 46 (23 its own); citations of its devices by later devices: 57 (23 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sorin Biomedical, Inc.: 9 (https://510kreport.com/company/sorin-biomedical)
- Cobe Cardiovascular, Inc.: 7 (https://510kreport.com/company/cobe-cardiovascular)
- Shiley, Inc.: 3 (https://510kreport.com/company/shiley)
- Hospal Industrie: 1 (https://510kreport.com/company/hospal-industrie)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- Sorin Biomedica, Fiat, USA, Inc.: 1 (https://510kreport.com/company/sorin-biomedica-fiat-usa)
- Polystan A/S: 1 (https://510kreport.com/company/polystan-a-s)

## Firms that cite its devices most
- Sorin Group Italia S.R.L.: 24 (https://510kreport.com/company/sorin-group-italia)
- Cytori Therapeutics, Inc.: 2 (https://510kreport.com/company/cytori-therapeutics)
- Sorin Group Deutschland GmbH: 2 (https://510kreport.com/company/sorin-group-deutschland)
- Cobe Cardiovascular, Inc.: 2 (https://510kreport.com/company/cobe-cardiovascular)
- Mapquet Cardiopulmonary AG: 2 (https://510kreport.com/company/mapquet-cardiopulmonary)
- Livanova Deutschland, GmbH: 1 (https://510kreport.com/company/livanova-deutschland)
- Eurosets S.R.L: 1 (https://510kreport.com/company/eurosets)

## Its most-cited devices
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator (2002), cited by 6
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy (2002), cited by 5
- K004001: Monolyth Mimesys Hollow Fiber Oxygenator (2001), cited by 4
- K020647: Dideco Electa (2002), cited by 3
- K031223: Synthesis Mimesys Adult Membrane Oxygenator (2003), cited by 3
- K001388: Data Master Perfusion Monitoring System (2000), cited by 3

## Recent decisions
- K052717: D732 Micro 27 PH.I.S.I.O. Adult Arterial Filter (Oct 20, 2005)
- K051232: D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O Pediatric Arterial Filter (May 20, 2005)
- K050890: Ecc.O System (May 5, 2005)
- K050447: Performa Adult Hollow Fiber Membrane Oxygenator (Mar 8, 2005)
- K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (Feb 1, 2005)
- K041061: D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (May 6, 2004)
- K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating (Jan 13, 2004)
- K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters (Jan 8, 2004)

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