Optima Series II Model 147B Single Chamber Pulse
FDA 510(k) K903186 · Telectronics Pacing Systems, Inc.
510(k) numberK903186
Submission
- Device name
- Optima Series II Model 147B Single Chamber Pulse
- Applicant
- Telectronics Pacing Systems, Inc.
Englewood, CO, US - Received
- July 19, 1990
- Decision date
- January 18, 1991
- 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 |
|---|---|---|
| K961118 | Maxim PF Models 033-581/033-590DTB · Traditional | 07/15/1996ST |
| K943657 | SterilizationDTB · Traditional | 06/24/1996ST |
| K934899 | Bifurcated Lead Adaptors, 3.2MM & 5.0 MMDTD · Traditional | 05/12/1994SE |
| K926340 | New Lead Introducer Kits, Various ModelsDYB · Traditional | 05/27/1993SE |
| K914489 | New Extrusion Vendor for Polyurethane TubingDTB · Traditional | 08/17/1992SE |
| K913919 | Universal Terminal Cap, 3.2MMKFJ · Traditional | 12/31/1991SE |
| K912773 | Unipolar Upsizing AdaptorDTD · Traditional | 10/23/1991SE |
| K911273 | 100 CM Permanent Pacing Lead ModelsDTB · Traditional | 08/28/1991SE |
| K910112 | Bifurcated VS-1 to VS-1 Lead AdaptorDTD · Traditional | 02/25/1991SE |
| K904741 | Laserdish Poly Unipolar Ventri Lead W/Trail TinesDTB · Traditional | 01/08/1991SE |
Questions and answers
When was Optima Series II Model 147B Single Chamber Pulse cleared by the FDA?
Optima Series II Model 147B Single Chamber Pulse (K903186) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 183 days after the submission was received.
What is the product code of K903186?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.