Model 228-02 Thinlith II Pacemaker, Bipo
FDA 510(k) K791379 · Intermedics, Inc.
510(k) numberK791379
Submission
- Device name
- Model 228-02 Thinlith II Pacemaker, Bipo
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- July 24, 1979
- Decision date
- September 12, 1979
- 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 |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Model 228-02 Thinlith II Pacemaker, Bipo cleared by the FDA?
Model 228-02 Thinlith II Pacemaker, Bipo (K791379) received a 510(k) decision of Substantially Equivalent on September 12, 1979, 50 days after the submission was received.
What is the product code of K791379?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.