AccuCath Intravascular Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153298 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AccuCath Intravascular Catheter is a therapeutic intravascular device designed for short-term use less than 30 days. It is intended for vascular access and administration of fluids or medications.
This catheter is supplied in various sizes including 22GX1.25 and 20GX2.25. It is a single-use device and requires appropriate storage conditions. The device has FDA 510K clearance with product code FOZ and K-number K153298.
Frequently asked questions
What is the AccuCath Intravascular Catheter used for?
The AccuCath Intravascular Catheter is designed for short-term vascular access and administration of fluids or medications, intended for use less than 30 days. It provides a reliable solution for therapeutic intravascular procedures.
What sizes are available for the AccuCath Intravascular Catheter?
The AccuCath Intravascular Catheter is supplied in various sizes including 22GX1.25 and 20GX2.25, allowing clinicians to select the appropriate size for specific patient needs and vascular access requirements.
Is the AccuCath Intravascular Catheter single-use or reusable?
The AccuCath Intravascular Catheter is a single-use device, designed for one-time use only to ensure patient safety and prevent cross-contamination. Proper disposal after use is required.
What is the regulatory status of the AccuCath Intravascular Catheter?
The AccuCath Intravascular Catheter has FDA 510K clearance with product code FOZ and K-number K153298, indicating it has been determined to be substantially equivalent to predicate devices for its intended use.
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: AccuCath Ace™ Intravascular Catheter | BD, MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ..., MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ..., PDF AccuCath Ace™ Intravascular Catheter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153298 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K153298 24 fields · synced Sep 28, 2026