Disp. Tougy-Borst Type Adaptor W/Port
FDA 510(k) K802328 · Stanco Medical, Inc.
510(k) numberK802328
Submission
- Device name
- Disp. Tougy-Borst Type Adaptor W/Port
- Applicant
- Stanco Medical, Inc.
Mchenry, IL, US - Received
- September 23, 1980
- Decision date
- October 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K810643 | Universal Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K810642 | Atrial-Ventricular Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K802289 | Pericardiocentesis KitDOR · Traditional | 11/26/1980SE |
| K802288 | Swan Ganz Catheter Placement KitDYG · Traditional | 11/20/1980SE |
| K802287 | Right Atrial Line KitDQY · Traditional | 11/20/1980SE |
| K802259 | Transvenous Pacemaker Electrode KitLDF · Traditional | 10/23/1980SE |
| K802290 | Regional Intravenous Anesthesia KitCAZ · Traditional | 10/17/1980SE |
| K802327 | Sheath Dilator SetDRE · Traditional | 10/10/1980SE |
| K802326 | Pressure Monitoring LinesDRI · Traditional | 10/10/1980SE |
| K802260 | Vascular Catheter WireguidesDQX · Traditional | 10/10/1980SE |
Questions and answers
When was Disp. Tougy-Borst Type Adaptor W/Port cleared by the FDA?
Disp. Tougy-Borst Type Adaptor W/Port (K802328) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 17 days after the submission was received.
What is the product code of K802328?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.