UsCi Coronary Infusion Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K891069 FDA 510(k)
- FDA Product Code
- DQY 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 Coronary Infusion Catheter is a coronary infusion catheter, classified as a Class 2 device with product code DQY. It is substantially equivalent to other devices and has a clearance type of traditional. The device is used for infusion in coronary applications. It is a type of cardiovascular catheter.
The UsCi Coronary Infusion Catheter is supplied by C.R. Bard, Inc. and has FDA 510K authorizations. The device has a k number of K891069 and was cleared on August 9, 1989. It is manufactured in the US and has a specific address associated with its production.
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 Coronary Infusion Catheter - C.R. Bard | FDA Evidence Review, USCI CORONARY INFUSION CATHETER (K891069) - FDA 510 (k), USCI CORONARY INFUSION CATHETER (K891069) — FDA 510 (k) | Innolitics, USCI CORONARY INFUSION… — K891069 · DeviceClearance, K810412 FDA 510 (k) - USCI CARDIOVASCULAR CATHETER
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K891069 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K891069 24 fields · synced Sep 24, 2026