Maxima Filtered HardShell Reservoir
510(k) K932254
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESP | NumberK932254 | Date3 Aug 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DTB
- Device class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory committee
- Cardiovascular
- FDA decision
- SESP Substantially Equivalent — Postmarket Surveillance
Overview
AI-generated summary, 18 Sep 2026
The Maxima Filtered HardShell Reservoir is a Permanent Pacemaker Electrode, designed as a reservoir component for cardiac pacing systems. It incorporates a hard-shell construction with filtration to ensure compatibility with pacing leads and electrode systems, facilitating reliable electrical conduction while minimizing contamination risk.
This device is supplied sterile and intended for single-use in cardiovascular procedures. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and requires FDA 510(k) clearance (K932254). The reservoir is compatible with pacemaker systems and must be handled under aseptic conditions prior to implantation, adhering to standard sterile field protocols.