Vas-Cath Continous Epidural Anesth. Cath/Kit/Tray
FDA 510(k) K844982 · Vas-Cath of Canada , Ltd.
510(k) numberK844982
Submission
- Device name
- Vas-Cath Continous Epidural Anesth. Cath/Kit/Tray
- Applicant
- Vas-Cath of Canada , Ltd.
Ontario, L5a 3v3, CA - Received
- December 26, 1984
- Decision date
- January 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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| K190345 | VPCCAZ · Traditional | PAJUNK GmbH Medizintechnologie | 05/16/2019SE |
| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | Teleflex, Inc. | 06/21/2016SE |
| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
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More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | 07/16/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | 10/24/1986SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | 08/22/1985SE |
| K844854 | Opti-Flow Digital Subtraction Angiography Cat-KitDQO · Traditional | 05/21/1985SE |
| K844800 | Opti-Flow & Opti-Torque Angiographic CathetersDQO · Traditional | 05/16/1985SE |
| K850009 | Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional | 05/13/1985SE |
| K844434 | Vaccess 3000 Single Lumen Jugular Cannula-CathLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Vas-Cath Continous Epidural Anesth. Cath/Kit/Tray cleared by the FDA?
Vas-Cath Continous Epidural Anesth. Cath/Kit/Tray (K844982) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 23 days after the submission was received.
What is the product code of K844982?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.