Identifiers
- 510(k) Number
- K993139 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
- Models / Variants
- Yp 45/15-Bp FDA 510(k)Yp 53/15-Bp FDA 510(k)Yp 60/15-Bp FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- ST FDA 510(k)
These devices are Permanent Pacemaker Electrodes, classified as Class III medical devices, designed for active fixation within the heart. They feature a bipolar (BP) IS-1 connector configuration and are intended for pacing and sensing in cardiac rhythm management applications.
The YP 45/15-BP, YP 53/15-BP, and YP 60/15-BP leads are supplied sterile and intended for single-use implantation. They are compatible with implantable pulse generators and are regulated under FDA 510(k) clearance (K993139) as substantially equivalent with tracking requirements. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
Are these pacemaker leads designed for reuse after a single implantation, or can they be used multiple times?
These leads (YP 45/15-BP, YP 53/15-BP, YP 60/15-BP) are explicitly labeled for single-use implantation only. The manufacturer’s instructions emphasize sterile handling and compliance with sterile medical device protocols, which aligns with their intended use as disposable devices. Reuse is not supported or recommended.
What connector type and compatibility should I confirm when selecting these leads for a pacemaker system?
All three models feature a bipolar (BP) IS-1 connector, which is a standard interface for permanent pacemaker electrodes. They are designed to be compatible with implantable pulse generators that support this connector type. Always verify the specific pulse generator’s documentation to ensure mechanical and electrical compatibility before use.
How should these leads be stored to maintain sterility and functionality before implantation?
Since these leads are supplied sterile, they must be stored according to sterile medical device protocols. This typically includes keeping them in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing them to moisture or contamination, as this could compromise sterility or integrity before use.
What distinguishes the YP 45/15-BP, YP 53/15-BP, and YP 60/15-BP models from each other?
The numerical differences in the model names (e.g., 45, 53, 60) likely refer to electrode tip designs or lead lengths, which may influence placement or fixation within the heart. While the exact specifications (e.g., tip diameter, coil length) aren’t detailed here, the active fixation feature is consistent across all three. Always consult the manufacturer’s technical documentation or product inserts for precise sizing or clinical application guidance tailored to your patient’s anatomy.
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: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993139 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K993139 24 fields · synced Sep 18, 2026