Pacemaker Programmer #2010
FDA 510(k) K811217 · Cardiac Pacemakers, Inc.
510(k) numberK811217
Submission
- Device name
- Pacemaker Programmer #2010
- Applicant
- Cardiac Pacemakers, Inc.
Mchenry, IL, US - Received
- May 4, 1981
- Decision date
- July 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRG – Programmer, Pacemaker
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3700
- Specialty
- Cardiovascular
Other 510(k)s with product code KRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | Intermedics, Inc. | 03/15/1995SE |
| K884522 | Model 5650 Optimate Personal ProgrammerKRG · Traditional | Teletronics, Inc. | 08/25/1989SE |
| K880738 | Model 2331T Patient ProgrammerKRG · Traditional | Medtronic Vascular | 11/17/1988SE |
| K882429 | Model 255A Programmer III, W/Software Revi. 4004KRG · Traditional | Tpl-Cordis, Inc. | 07/22/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | Telectronics, Inc. | 12/17/1987SE |
| K871986 | Model 5600B Programmer, PacemakerKRG · Traditional | Telectronics, Inc. | 06/24/1987SE |
| K863046 | Ultra Software Module: Model 2016KRG · Traditional | Cardiac Pacemakers, Inc. | 12/05/1986SE |
| K863045 | Programmer Model 2035/ELECTROGRAM Cable Model 6580KRG · Traditional | Cardiac Pacemakers, Inc. | 09/29/1986SE |
| K860584 | Software MODULE/2035 Prog and Astra/T Pulse GenKRG · Traditional | Cardiac Pacemakers, Inc. | 06/06/1986SE |
| K860546 | Dialog Programmer 700 - Program Version 6.37KRG · Traditional | Pacesetter Systems | 04/23/1986SE |
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|---|---|---|
| K093969 | Acuity Break-Away Guide CatheterDQY · Special | 03/05/2010SE |
| K080154 | Acuity Universal CutterDQY · Special | 03/20/2008SE |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K920601 | Astra T2, Astra T4, Astra T6DXY · Traditional | 10/28/1992SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K875147 | Torque Hex WrenchDTF · Traditional | 01/27/1988SE |
Questions and answers
When was Pacemaker Programmer #2010 cleared by the FDA?
Pacemaker Programmer #2010 (K811217) received a 510(k) decision of Substantially Equivalent on July 20, 1981, 77 days after the submission was received.
What is the product code of K811217?
The FDA product code is KRG – Programmer, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3700.