Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3630](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3630) → DTC — Analyzer, Pacemaker Generator Function # DTC · Analyzer, Pacemaker Generator Function _Cardiovascular · 21 CFR 870.3630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC ## Overview - **Product Code:** DTC - **Device Name:** Analyzer, Pacemaker Generator Function - **Regulation:** [21 CFR 870.3630](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3630) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K170815](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K170815.md) | PSA Cable | Boston Scientific Corporation | Jul 6, 2017 | SESE | | [K083674](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K083674.md) | PK-141 PATIENT CABLE | Biotronik, Inc. | Apr 1, 2009 | SESE | | [K011729](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K011729.md) | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | Dni Nevada, Inc. | Aug 30, 2001 | SESE | | [K002497](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K002497.md) | MODEL 4810 ANALYZER OUTPUT ADAPTER | Pace Medical | Oct 10, 2000 | SESE | | [K961582](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K961582.md) | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | North American Technical Services Corp. | Nov 8, 1996 | SESE | | [K903966](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K903966.md) | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | Bio-Tek Instruments, Inc. | Jun 19, 1991 | SESE | | [K910595](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K910595.md) | MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | May 7, 1991 | SESE | | [K910223](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K910223.md) | CPI MODEL 2215/SEAMED MODEL 3400 | Seamed Corp. | Mar 19, 1991 | SESE | | [K901332](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K901332.md) | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | Biotronik, GmbH & Co. | May 9, 1990 | SESE | | [K896632](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K896632.md) | MEDTRONIC MODEL 5401B TEST CABLE | Medtronic Vascular | Dec 13, 1989 | SESE | | [K884331](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K884331.md) | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | Jan 10, 1989 | SESE | | [K882327](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K882327.md) | PACER SENSING ANALYZER (PSA 100) | Oscor Medical Corp. | Oct 6, 1988 | SESE | | [K860462](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K860462.md) | SEAMED MODEL 3000 | Seamed Corp. | Aug 19, 1986 | SESE | | [K851900](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K851900.md) | SEA MED DDD PACING SYSTEM ANALYZER | Seamed Corp. | Jul 19, 1985 | SESE | | [K850077](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K850077.md) | MEDTRONIC 5311 PACING SYSTEM ANALYZER | Medtronic Vascular | Jul 16, 1985 | SESE | | [K844969](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K844969.md) | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | Cordis Corp. | May 1, 1985 | SESE | | [K831697](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K831697.md) | TELECTRONICS MODEL 2401 | Seamed Corp. | Sep 4, 1984 | SESE | | [K812262](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K812262.md) | MEDTRONIC A-V PACING SYSTEM ANALYZER | Medtronic Vascular | Jun 17, 1982 | SESE | | [K810604](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K810604.md) | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | Telectronics, Inc. | Apr 14, 1981 | SESE | | [K792602](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K792602.md) | SUSI II PACEMAKER SURVEILLANCE MONITOR | Ela Medical, Inc. | Mar 25, 1980 | SESE | ## Top Applicants - Medtronic Vascular — 5 clearances - Seamed Corp. — 4 clearances - Instromedix, Inc. — 3 clearances - Cordis Corp. — 2 clearances - Ela Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com