Pacing Kit, Semi-Floating
FDA 510(k) K770018 · Electro-Catheter Corp.
510(k) numberK770018
Submission
- Device name
- Pacing Kit, Semi-Floating
- Applicant
- Electro-Catheter Corp.
Walker, MI, US - Received
- January 4, 1977
- Decision date
- January 14, 1977
- 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 |
|---|---|---|
| K934785 | MultipaceLDF · Traditional | 07/27/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K934787 | Silicore Semi-FloaterLDF · Traditional | 02/24/1995SE |
| K874154 | Elecath(R) Transesophageal Pacing CatheterKNT · Traditional | 04/29/1988SE |
| K854511 | Elecath Percutaneous Left Atrial Cannulation SetDQX · Traditional | 02/10/1986SE |
| K854975 | Elecath Pulsatile Perfusion PumpKFM · Traditional | 01/15/1986SE |
| K850065 | Elecath Torkfloat Pacing ProbeDTB · Traditional | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | 03/27/1985SE |
Questions and answers
When was Pacing Kit, Semi-Floating cleared by the FDA?
Pacing Kit, Semi-Floating (K770018) received a 510(k) decision of Substantially Equivalent on January 14, 1977, 10 days after the submission was received.
What is the product code of K770018?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.