Intersept*Crystalloid Cardioplegia Delivery System
FDA 510(k) K883439 · Medtronic Blood Systems, Inc.
510(k) numberK883439
Submission
- Device name
- Intersept*Crystalloid Cardioplegia Delivery System
- Applicant
- Medtronic Blood Systems, Inc.
Anaheim, CA, US - Received
- August 15, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
More from Quest Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944966 | Unipolar Atrial Temporary Pacing Lead,Model 6492LDF · Traditional | 07/14/1995SE |
| K944957 | Temporary Myocardial Pacing Lead, Model 6500LDF · Traditional | 07/14/1995SE |
| K893207 | Closed Chest Support CircuitDTZ · Traditional | 12/12/1989SE |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HKRH · Traditional | 11/27/1989SE |
| K891687 | Extracorporeal Circuit with Bio-Active SurfaceDTZ · Traditional | 05/31/1989SE |
| K891230 | Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.DTZ · Traditional | 05/19/1989SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | 12/05/1988SE |
| K883086 | Intersept*Prebypass FilterKRJ · Traditional | 09/16/1988SE |
Questions and answers
When was Intersept*Crystalloid Cardioplegia Delivery System cleared by the FDA?
Intersept*Crystalloid Cardioplegia Delivery System (K883439) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 59 days after the submission was received.
What is the product code of K883439?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.