DTA · Tester, Pacemaker Electrode Function
Cardiovascular · 21 CFR 870.3720 · Class 2
Overview
| Product Code | DTA |
|---|---|
| Device Name | Tester, Pacemaker Electrode Function |
| Regulation | 21 CFR 870.3720 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | Feb 28, 2017 | SESE |
| K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | St Jude Medical, Crmd | Dec 21, 2010 | SESE |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | Dec 20, 2007 | SESE |
| K050884 | ADAPTER CABLE | Remington Medical, Inc. | May 19, 2005 | SESE |
| K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | Dec 8, 2003 | SESE |
| K022360 | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. | Biotronik, Inc. | Jan 27, 2003 | SESE |
| K933069 | MODEL EP-2 CLINICAL STIMULATOR | Ep Medical, Inc. | Oct 21, 1993 | SESE |
| K812104 | SIEMENS-ELEMA PSA 376 | Siemens Corp. | Dec 2, 1981 | SESE |
| K791380 | VA 1000 | Vitatron Medical BV | Sep 19, 1979 | SESE |
| K790503 | CARDIOTEST 2200 | Cardiac Pacemakers, Inc. | May 17, 1979 | SESE |
Top Applicants
- Biotronik, Inc. — 3 clearances
- Cardiac Pacemakers, Inc. — 1 clearance
- Ep Medical, Inc. — 1 clearance
- Medtronic, Inc. — 1 clearance
- Remington Medical, Inc. — 1 clearance
