DTC — Analyzer, Pacemaker Generator Function Class II
FDA product code DTC covers "Analyzer, Pacemaker Generator Function", a Class II medical device regulated under 21 CFR 870.3630. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |