Lead Introducer SETS-EB-S8 & EB-S12
FDA 510(k)Class II (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K831751 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Lead Introducer Sets-EB-S8 & EB-S12 are cardiovascular devices classified under product code DYB. These sets are designed for introducing leads in medical procedures.
The Lead Introducer Sets-EB-S8 & EB-S12 are supplied by Oscor Inc. and were cleared by the FDA under the 510k pathway on October 20, 1983. They are Class 2 devices and are available in models EB-S8 and EB-S12.
Frequently asked questions
What are the Lead Introducer Sets-EB-S8 & EB-S12 used for?
These sets are cardiovascular devices designed specifically for introducing leads in medical procedures, with models EB-S8 and EB-S12 available to meet different procedural requirements.
How are the Lead Introducer Sets-EB-S8 & EB-S12 supplied?
The Lead Introducer Sets-EB-S8 & EB-S12 are supplied by Oscor Inc. and are available in two distinct models, EB-S8 and EB-S12, to accommodate various procedural needs.
What is the regulatory status of the Lead Introducer Sets-EB-S8 & EB-S12?
These devices were cleared by the FDA under the 510k pathway on October 20, 1983, and are classified as Class 2 devices under product code DYB for cardiovascular procedures.
Are there different sizes or models available for the Lead Introducer Sets?
Yes, the Lead Introducer Sets are available in two models: EB-S8 and EB-S12, which may be designed for different procedural specifications or anatomical considerations.
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: LEAD INTRODUCER SETS-EB-S8 & EB-S12 (K831751) — FDA 510 (k) | Innolitics, lead introducer sets-eb-s8 eb-s12 - lavascular.com, LEAD INTRODUCER SETS-EB-S8 & EB-S12 (K831751) — FDA 510 (k) | Innolitics, K073100 FDA 510(k) - INTRODUCER SETS | Oscor, Inc., Integer | Products - Oscor Introducers
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831751 | Class II | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K831751 24 fields · synced Oct 1, 2026