Tester, Pacemaker Electrode Function
The Pacemaker Electrode Function Tester is a cardiovascular test device used to assess the electrical performance of pacemaker leads and electrodes, verifying sensing and pacing thresholds before or during implantation or follow-up procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTA and it is regulated under 21 CFR 870.3720 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DTA
- Device Class
- FDA class 2
- Regulation Number
- 870.3720
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Feb 28, 2017 | Substantially Equivalent | Medtronic, Inc. |
| K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | Dec 21, 2010 | Substantially Equivalent | St Jude Medical, Crmd |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Dec 20, 2007 | Substantially Equivalent | Biotronik, Inc. |
| K050884 | ADAPTER CABLE | May 19, 2005 | Substantially Equivalent | Remington Medical, Inc. |
| K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Dec 08, 2003 | Substantially Equivalent | Biotronik, Inc. |
| 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. | Jan 27, 2003 | Substantially Equivalent | Biotronik, Inc. |
| K933069 | MODEL EP-2 CLINICAL STIMULATOR | Oct 21, 1993 | Substantially Equivalent | Ep Medical, Inc. |
| K812104 | SIEMENS-ELEMA PSA 376 | Dec 02, 1981 | Substantially Equivalent | Siemens Corp. |
| K791380 | VA 1000 | Sep 19, 1979 | Substantially Equivalent | Vitatron Medical BV |
| K790503 | CARDIOTEST 2200 | May 17, 1979 | Substantially Equivalent | Cardiac Pacemakers, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.