Model 327D, Series R Unipolar Cardiac Pulse Gener.
FDA 510(k) K860202 · Cook Pacemaker Corp.
510(k) numberK860202
Submission
- Device name
- Model 327D, Series R Unipolar Cardiac Pulse Gener.
- Applicant
- Cook Pacemaker Corp.
Leechburg, PA, US - Received
- January 22, 1986
- Decision date
- February 24, 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 |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K970690 | Locking Stylet 2DQX · Traditional | 05/20/1997SE |
| K961992 | Needle's Eye SnareDXE · Traditional | 12/27/1996SE |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | 09/29/1995ST |
| K915188 | Model P In-Line Bipolar Endocardial Tined LeadDTB · Traditional | 09/11/1992SESP |
| K905403 | Model 340 Series Unipolar & Model 5000B ProgrammerDXY · Traditional | 10/16/1991SE |
| K863582 | Model 725TH Handheld Transceiver (Programmer)DXY · Traditional | 10/08/1986SE |
| K861559 | Series (T) Programmable Cardiac Pulse GeneratorsDXY · Traditional | 05/09/1986SE |
| K860466 | Model 329D, Seriers R Biopolar Cardiac Pul. Gen.DXY · Traditional | 02/24/1986SE |
| K854919 | Bipolar Cardiac Pulse Generator with TelemetryDXY · Traditional | 12/19/1985SE |
| K854132 | Cook Pacemaker 332T, Series R Bipolar Cardiac PulsDXY · Traditional | 12/03/1985SE |
Questions and answers
When was Model 327D, Series R Unipolar Cardiac Pulse Gener. cleared by the FDA?
Model 327D, Series R Unipolar Cardiac Pulse Gener. (K860202) received a 510(k) decision of Substantially Equivalent on February 24, 1986, 33 days after the submission was received.
What is the product code of K860202?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.