Identifiers
- 510(k) Number
- K914128 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Connecting Set is a medical device used for connecting components in cardiovascular procedures. It is manufactured by Procedure Products, Inc. and has the model number K914128 with product code DQO.
This device is supplied as a single-use item and is not MRI compatible. It received FDA 510(k) clearance on November 27, 1991, and is regulated under the cardiovascular advisory committee. The device should be stored according to the manufacturer's instructions and is authorized for use in medical settings.
Frequently asked questions
What is the Connecting Set used for?
The Connecting Set is a medical device designed for connecting components in cardiovascular procedures. It is manufactured by Procedure Products, Inc. with model number K914128 and product code DQO.
Is the Connecting Set reusable or single-use?
The Connecting Set is supplied as a single-use item and should not be reused. It is designed for one-time use only to ensure patient safety and device performance.
What are the storage requirements for the Connecting Set?
The Connecting Set should be stored according to the manufacturer's instructions. Proper storage conditions help maintain the device's integrity and ensure it functions as intended when used.
What regulatory approvals does the Connecting Set have?
The Connecting Set received FDA 510(k) clearance on November 27, 1991, and is regulated under the cardiovascular advisory committee. It is classified under product code DQO.
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: CONNECTING SET (K914128) — FDA 510(k) | Innolitics, Procedure Products, Connecting Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914128 | Class II | Active |
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Manufacturer
- Manufacturer
- Procedure Products, Inc.
Sources (1)
- FDA 510(k) K914128 24 fields · synced Sep 24, 2026