Fastpass Implantable Endocard. Pacing
by Pacesetter Systems 510(k)
Active
510(k) K821947
Overview
The FastPass Implantable Endocardial Pacing Electrode is a permanent pacemaker electrode designed for transvenous implantation within the heart. It delivers electrical stimulation to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring proper pacing of the heart chambers via endocardial contact.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as cardiac catheterization labs or operating rooms. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a 510(k) clearance (K821947) for substantial equivalence. Multiple model references are associated with its regulatory submission, including 3002618605, 3008377825, and others, ensuring traceability and compliance with U.S. medical device standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821947 | Date6 Aug 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What types of patients is this device intended to support with pacing therapy?
The FastPass Implantable Endocardial Pacing Electrode is designed for patients with bradycardia or conduction disorders who require transvenous cardiac pacing. It delivers electrical stimulation directly to the heart’s endocardium to regulate rhythm, ensuring proper pacing of heart chambers in clinical settings like catheterization labs or operating rooms.
Is this device reusable, or is it meant for single-use only?
This device is supplied sterile and explicitly intended for single-use implantation by qualified healthcare professionals. It is not designed for reuse, as repeated use could compromise sterility and performance.
How is this device classified under U.S. regulations, and what does that mean for its use?
The FastPass Implantable Endocardial Pacing Electrode is classified as a Class III medical device under FDA regulations (21 CFR 870.3680), meaning it requires a 510(k) clearance for market authorization. This classification reflects its role in life-sustaining or life-supporting functions, ensuring rigorous oversight for safety and efficacy in pacing therapy.
What are the key model references or identifiers for this device, and why are they important?
This device includes multiple model references (e.g., 3002618605, 3008377825, 3008988055) tied to its FDA submission (K821947). These identifiers ensure traceability for compliance, inventory management, and regulatory tracking, as they correspond to specific lot or batch details in the manufacturer’s records.
Where and how should this device be stored before use to maintain its integrity?
Since the FastPass electrode is supplied sterile, it must be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediate pre-procedure preparation to preserve sterility and functionality for transvenous implantation.