Orion 40 Cardiac Stimulator & PMP 200 Programmer
FDA 510(k) K852641 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK852641
Submission
- Device name
- Orion 40 Cardiac Stimulator & PMP 200 Programmer
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
New York, NY, US - Received
- June 20, 1985
- Decision date
- January 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXY – Implantable Pacemaker Pulse-Generator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3610
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | Biotronik, Inc. | 11/10/1999SE |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | Ela Medical, Inc. | 08/29/1997ST |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | Biotronik, Inc. | 03/04/1996SESP |
| K954092 | Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953866 | Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | Cook Pacemaker Corp. | 09/29/1995ST |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | Biotronik, Inc. | 09/29/1995ST |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | Ela Medical, Inc. | 09/01/1995ST |
| K940039 | Pellethane 75DDXY · Traditional | Medtronic Vascular | 07/12/1995ST |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional | Medtronic Vascular | 05/15/1995ST |
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| 510(k) | Device | Decision |
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| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | 05/27/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
| K925615 | Shiley Specialized,Pediatric & Neonatal Trach.TubeCBI · Traditional | 03/26/1993SE |
| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | 03/26/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | 02/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | 02/02/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | 11/30/1992SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K851365 | Sorin Biomedica Orion 30/A Cardiac Stimulator & PMDXY · Traditional | 12/03/1985SE |
| K841948 | Testosterone Direct RadioimmunoassayCDZ · Traditional | 06/25/1984SE |
Questions and answers
When was Orion 40 Cardiac Stimulator & PMP 200 Programmer cleared by the FDA?
Orion 40 Cardiac Stimulator & PMP 200 Programmer (K852641) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 208 days after the submission was received.
What is the product code of K852641?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.