Product Code: DTC
FDA class 2
21 CFR 870.3630
Analyzer, Pacemaker Generator Function
Cardiovascular
The Pacemaker Generator Function Analyzer is a cardiovascular diagnostic device used to evaluate the output, sensing function, and battery status of an implanted or external pacemaker generator, supporting device follow-up and programming. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTC and it is regulated under 21 CFR 870.3630 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
30
FEI Numbers
6
Registration Numbers
6
Unique Applicants
19
Years Active
41
Basic Information
- Product Code
- DTC
- Device Class
- FDA class 2
- Regulation Number
- 870.3630
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 30 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170815 | PSA Cable | Jul 06, 2017 | Substantially Equivalent | Boston Scientific Corporation |
| K083674 | PK-141 PATIENT CABLE | Apr 01, 2009 | Substantially Equivalent | BIOTRONIK, INC. |
| K011729 | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | Aug 30, 2001 | Substantially Equivalent | DNI NEVADA, INC. |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | Oct 10, 2000 | Substantially Equivalent | PACE MEDICAL |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | Nov 08, 1996 | Substantially Equivalent | NORTH AMERICAN TECHNICAL SERVICES CORP. |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | Jun 19, 1991 | Substantially Equivalent | BIO-TEK INSTRUMENTS, INC. |
| K910595 | MODEL 5311B A-V PACING SYSTEM ANALYZER | May 07, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | Mar 19, 1991 | Substantially Equivalent | SEAMED CORP. |
| K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | May 09, 1990 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K896632 | MEDTRONIC MODEL 5401B TEST CABLE | Dec 13, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K884331 | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | Jan 10, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K882327 | PACER SENSING ANALYZER (PSA 100) | Oct 06, 1988 | Substantially Equivalent | OSCOR MEDICAL CORP. |
| K860462 | SEAMED MODEL 3000 | Aug 19, 1986 | Substantially Equivalent | SEAMED CORP. |
| K851900 | SEA MED DDD PACING SYSTEM ANALYZER | Jul 19, 1985 | Substantially Equivalent | SEAMED CORP. |
| K850077 | MEDTRONIC 5311 PACING SYSTEM ANALYZER | Jul 16, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K844969 | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | May 01, 1985 | Substantially Equivalent | CORDIS CORP. |
| K831697 | TELECTRONICS MODEL 2401 | Sep 04, 1984 | Substantially Equivalent | SEAMED CORP. |
| K812262 | MEDTRONIC A-V PACING SYSTEM ANALYZER | Jun 17, 1982 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K810604 | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | Apr 14, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR | Mar 25, 1980 | Substantially Equivalent | ELA MEDICAL, INC. |
| K800286 | CRITERION II PACING SYSTEM MONITORS | Mar 12, 1980 | Substantially Equivalent | DART MEDICAL EQUIPMENT |
| K791975 | PACING SYSTEM ANALYZER PSA SCE-22 | Jan 31, 1980 | Substantially Equivalent | ELA MEDICAL, INC. |
| K792074 | MODEL 674 PACER ANALYZER | Dec 27, 1979 | Substantially Equivalent | DEL MAR AVIONICS |
| K791762 | SELF CHECK | Sep 21, 1979 | Substantially Equivalent | INSTROMEDIX, INC. |
| K781349 | PACER-TRACER PULSE WIDTH | Aug 31, 1978 | Substantially Equivalent | INSTROMEDIX, INC. |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | Aug 23, 1978 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K780717 | EXTERNAL TEST PULSE GENERATOR | Jun 30, 1978 | Substantially Equivalent | VITATRON MEDICAL BV |
| K771922 | MINICLINIC TM | Nov 02, 1977 | Substantially Equivalent | INSTROMEDIX, INC. |
| K770865 | MONITOR, PACEMAKER | Jun 14, 1977 | Substantially Equivalent | ADCOR ELECTRONICS, INC. |
| K760013 | PACER SYSTEMS ANALYZER (CORDIS) | Jul 20, 1976 | Substantially Equivalent | CORDIS CORP. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.