Tray, Auxillary Block
FDA 510(k) K782069 · Pharmaseal Div., Baxter Healthcare Corp.
510(k) numberK782069
Submission
- Device name
- Tray, Auxillary Block
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
Mchenry, IL, US - Received
- December 13, 1978
- Decision date
- January 4, 1979
- 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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| 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 |
|---|---|---|
| K792369 | Hyperalimentation Dressing TrayFRG · Traditional | 12/10/1979SE |
| K792141 | Continuous Flush DeviceKRA · Traditional | 12/05/1979SE |
| K792019 | Phadecode Xa Inhibitor AssayJBQ · Traditional | 11/05/1979SE |
| K791773 | Ventilator Tube with FilterCAH · Traditional | 10/22/1979SE |
| K791156 | Amipaque Myelogram TrayFMI · Traditional | 07/30/1979SE |
| K790896 | Two-Way Anesthesia FilterCAH · Traditional | 06/05/1979SE |
| K790409 | Low Dead Space Insulin SyringeFMF · Traditional | 04/24/1979SE |
| K781797 | Prep Tray, Preoperative SkinOJU · Traditional | 11/08/1978SE |
| K781680 | Monitoring, Pressure KitDRS · Traditional | 10/06/1978SE |
| K780887 | Improved Disposable Hypodermic NeedleGAA · Traditional | 06/22/1978SE |
Questions and answers
When was Tray, Auxillary Block cleared by the FDA?
Tray, Auxillary Block (K782069) received a 510(k) decision of Substantially Equivalent on January 4, 1979, 22 days after the submission was received.
What is the product code of K782069?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.