USCI Gruntzig Dilaca Balloon Dilation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K830608 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The USCI Gruntzig Dilaca Balloon Dilation is a catheter used for angioplasty in peripheral vessels through transluminal procedures. It is designed for dilating narrowed or obstructed blood vessels to restore blood flow.
This device is supplied by C.R. Bard, Inc. and is classified as Class II under special controls with product code LIT. It received FDA 510(k) clearance on March 24, 1983, and is intended for single-use in cardiovascular procedures.
Frequently asked questions
What is the USCI Gruntzig Dilaca Balloon Dilation used for?
The USCI Gruntzig Dilaca Balloon Dilation is a catheter used for angioplasty in peripheral vessels through transluminal procedures. It is designed to dilate narrowed or obstructed blood vessels to restore blood flow.
Is the USCI Gruntzig Dilaca Balloon Dilation a single-use device?
Yes, the USCI Gruntzig Dilaca Balloon Dilation is intended for single-use in cardiovascular procedures. It should not be reused on multiple patients due to infection risks and potential device degradation.
What is the regulatory classification of the USCI Gruntzig Dilaca Balloon Dilation?
The device is classified as Class II under special controls with product code LIT. It received FDA 510(k) clearance on March 24, 1983, and is substantially equivalent to other devices in its class.
Who manufactures the USCI Gruntzig Dilaca Balloon Dilation?
The USCI Gruntzig Dilaca Balloon Dilation is manufactured by C. R. Bard, Inc., located at 110 Marshall Dr., Warrendale, PA 15086, United States.
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: USCI GRUNTZIG DILACA BALLOON DILATION (K830608) - FDA 510 (k), USCI GRUNTZIG DILACA BALLOON DILATION - Innolitics, PDF K830608 - Usci Gruntzig Dilaca Balloon Dilation, Usci Gruntzig Dilaca Balloon Dilation - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K830608 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K830608 24 fields · synced Sep 28, 2026