Identifiers
- 510(k) Number
- K861851 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Siemens-Elema Sicard-P is a cardiac pacemaker, designed for temporary or permanent pacing of the heart. It delivers electrical impulses to regulate heart rhythm in patients experiencing bradycardia or other pacing-dependent conditions, ensuring consistent cardiac output.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals or cardiac care units. It requires proper sterilization and maintenance per manufacturer guidelines. The Sicard-P was cleared under FDA 510(k) K861851 in 1986, classified under the Product Code DPS for cardiovascular devices, and is regulated as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SIEMENS-ELEMA (SICARD-P) (K861851) — FDA 510 (k) | Innolitics, Mortara Instrument… — 51 FDA 510 (k)s · DeviceClearance, Mortara Instrument, Inc. FDA 510 (k) Products (1983-2019), K861992 FDA 510 (k) - MODEL 43200A CARDIAC MONITOR
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K861851 | Class II | Active |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (1)
- FDA 510(k) K861851 24 fields · synced Sep 18, 2026