Giant Lumen Safetip Series: Endomyocardial Biopsy
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K903840 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)
The Giant Lumen Safetip Series: Endomyocardial Biopsy is a medical device used for obtaining tissue samples from the heart muscle for diagnostic purposes. It is designed to facilitate endomyocardial biopsy procedures, allowing healthcare professionals to collect specimens for pathological examination.
This device is supplied as part of the Giant Lumen Safetip Series and is authorized under FDA 510K clearance with product code DYB. It is intended for single-use in clinical settings and should be stored according to the manufacturer's guidelines. The device is available in various sizes as specified by the model numbers included in the series.
Frequently asked questions
What is the Giant Lumen Safetip Series: Endomyocardial Biopsy used for?
This medical device is specifically designed for obtaining tissue samples from the heart muscle for diagnostic purposes. It facilitates endomyocardial biopsy procedures, allowing healthcare professionals to collect specimens for pathological examination.
How is the Giant Lumen Safetip Endomyocardial Biopsy supplied?
The device is supplied as part of the Giant Lumen Safetip Series and is available in various sizes as specified by the model numbers included in the series. It is intended for single-use in clinical settings.
What is the regulatory status of this device?
The Giant Lumen Safetip Series: Endomyocardial Biopsy is authorized under FDA 510K clearance with product code DYB. It received FDA clearance on October 16, 1990, and is classified as substantially equivalent.
How should this device be stored?
The device should be stored according to the manufacturer's guidelines. As a single-use device, proper storage conditions should be maintained until the device is ready for use to ensure its integrity and functionality.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903840 | Class II | Active |
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Manufacturer
- Manufacturer
- Intec Medical, Inc.
Sources (1)
- FDA 510(k) K903840 24 fields · synced Oct 6, 2026