Lilliput 1 New Born Hollow Fiber Oxygenator
FDA 510(k) K953835 · Dideco S.R.L.
510(k) numberK953835
Submission
- Device name
- Lilliput 1 New Born Hollow Fiber Oxygenator
- Applicant
- Dideco S.R.L.
Waltham, MA, US - Received
- August 16, 1995
- Decision date
- March 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K052717 | D732 Micro 27 Ph.I.S.I.O. Adult Arterial FilterDTM · Special | 10/20/2005SE |
| K051232 | D731 Micro 20 Ph.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 Ph.I.Si.O Pediatric…DTM · Special | 05/20/2005SE |
| K050890 | Ecc.O SystemKFM · Special | 05/05/2005SE |
| K050447 | Performa Adult Hollow Fiber Membrane OxygenatorDTZ · Special | 03/08/2005SE |
| K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDTZ · Abbreviated | 02/01/2005SE |
Questions and answers
When was Lilliput 1 New Born Hollow Fiber Oxygenator cleared by the FDA?
Lilliput 1 New Born Hollow Fiber Oxygenator (K953835) received a 510(k) decision of Substantially Equivalent on March 15, 1996, 212 days after the submission was received.
What is the product code of K953835?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.