Identifiers
- 510(k) Number
- K884200 FDA 510(k)
- FDA Product Code
- DTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4290 FDA 510(k)
- Regulation Number
- 870.4290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The USCI Tandem Adapter is a cardiovascular adaptor, stopcock, manifold, or fitting used in cardiopulmonary bypass systems. It is classified as a Class II medical device under product code DTL.
The device was cleared via the FDA 510(k) pathway under K884200 on December 5, 1988, following a traditional review. It is manufactured by C.R. Bard, Inc. and is intended for use in cardiovascular applications as indicated by its classification and advisory committee assignment.
Frequently asked questions
What is the USCI Tandem Adapter used for?
The USCI Tandem Adapter is a cardiovascular adaptor, stopcock, manifold, or fitting used in cardiopulmonary bypass systems, as indicated by its classification under product code DTL and its assignment to the Cardiovascular advisory committee.
How was the USCI Tandem Adapter cleared for market?
The device was cleared via the FDA 510(k) pathway under K884200 on December 5, 1988, following a traditional review process, and was found to be substantially equivalent to a predicate device.
Who manufactures the USCI Tandem Adapter and where is it made?
The USCI Tandem Adapter is manufactured by C.R. Bard, Inc., with the applicant address listed as 1200 Technology Park Dr., P.O. Box 7025, Billerica, MA 01821, 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: K884200 FDA 510 (k) - USCI TANDEM ADAPTER | C.R. Bard, Inc., Usci Tandem Adapter 510 (k) K884200 - FDA.report, PDF K884200 USCI TANDEM ADAPTER - 510kdatabase.net, Usci Div C R Bard Inc FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884200 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K884200 24 fields · synced Sep 28, 2026