DTC — Analyzer, Pacemaker Generator Function Class II
FDA Device Classification
Classification Details
- Product Code
- DTC
- Device Class
- Class II
- Regulation Number
- 870.3630
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K170815 | boston scientific corporation | PSA Cable | July 6, 2017 |
| K083674 | biotronik | PK-141 PATIENT CABLE | April 1, 2009 |
| K011729 | dni nevada | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | August 30, 2001 |
| K002497 | pace medical | MODEL 4810 ANALYZER OUTPUT ADAPTER | October 10, 2000 |
| K961582 | north american technical services | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | November 8, 1996 |
| K903966 | bio-tek instruments | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | June 19, 1991 |
| K910595 | medtronic vascular | MODEL 5311B A-V PACING SYSTEM ANALYZER | May 7, 1991 |
| K910223 | seamed | CPI MODEL 2215/SEAMED MODEL 3400 | March 19, 1991 |
| K901332 | biotronik, gmbh and | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | May 9, 1990 |
| K896632 | medtronic vascular | MEDTRONIC MODEL 5401B TEST CABLE | December 13, 1989 |
| K884331 | medtronic vascular | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | January 10, 1989 |
| K882327 | oscor medical | PACER SENSING ANALYZER (PSA 100) | October 6, 1988 |
| K860462 | seamed | SEAMED MODEL 3000 | August 19, 1986 |
| K851900 | seamed | SEA MED DDD PACING SYSTEM ANALYZER | July 19, 1985 |
| K850077 | medtronic vascular | MEDTRONIC 5311 PACING SYSTEM ANALYZER | July 16, 1985 |
| K844969 | cordis | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | May 1, 1985 |
| K831697 | seamed | TELECTRONICS MODEL 2401 | September 4, 1984 |
| K812262 | medtronic vascular | MEDTRONIC A-V PACING SYSTEM ANALYZER | June 17, 1982 |
| K810604 | telectronics | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | April 14, 1981 |
| K792602 | ela medical | SUSI II PACEMAKER SURVEILLANCE MONITOR | March 25, 1980 |