Regional Intravenous Anesthesia Kit
FDA 510(k) K802290 · Stanco Medical, Inc.
510(k) numberK802290
Submission
- Device name
- Regional Intravenous Anesthesia Kit
- Applicant
- Stanco Medical, Inc.
Mchenry, IL, US - Received
- September 19, 1980
- Decision date
- October 17, 1980
- 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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| K201356 | Plastic LOR SyringeCAZ · Traditional | Jiangsu Caina Medical Co.,Ltd | 02/12/2021SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | PAJUNK GmbH Medizintechnologie | 12/29/2020SE |
| 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 |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K810643 | Universal Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K810642 | Atrial-Ventricular Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K802289 | Pericardiocentesis KitDOR · Traditional | 11/26/1980SE |
| K802288 | Swan Ganz Catheter Placement KitDYG · Traditional | 11/20/1980SE |
| K802287 | Right Atrial Line KitDQY · Traditional | 11/20/1980SE |
| K802259 | Transvenous Pacemaker Electrode KitLDF · Traditional | 10/23/1980SE |
| K802328 | Disp. Tougy-Borst Type Adaptor W/PortDTZ · Traditional | 10/10/1980SE |
| K802327 | Sheath Dilator SetDRE · Traditional | 10/10/1980SE |
| K802326 | Pressure Monitoring LinesDRI · Traditional | 10/10/1980SE |
| K802260 | Vascular Catheter WireguidesDQX · Traditional | 10/10/1980SE |
Questions and answers
When was Regional Intravenous Anesthesia Kit cleared by the FDA?
Regional Intravenous Anesthesia Kit (K802290) received a 510(k) decision of Substantially Equivalent on October 17, 1980, 28 days after the submission was received.
What is the product code of K802290?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.