PMT 3721-1 Epidural Kit
FDA 510(k) K883314 · Progress Mankind Technology
510(k) numberK883314
Submission
- Device name
- PMT 3721-1 Epidural Kit
- Applicant
- Progress Mankind Technology
Chanhassen, MN, US - Received
- August 4, 1988
- Decision date
- October 28, 1988
- 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.
Other 510(k)s with product code CAZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | Arrow International, LLC | 02/13/2023SE |
| K210983 | BD Epilor SyringeCAZ · Traditional | Becton, Dickinson and Company | 05/19/2022SE |
| 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 |
|---|---|---|
| K881616 | PMT Mankind Lumbar-Peritoneal Shunt Model 1115-1JXG · Traditional | 09/09/1988SE |
| K871663 | PMT Traction TongsHAX · Traditional | 06/19/1987SE |
| K854157 | PMT Accupressure Infusion System 3601FRN · Traditional | 02/13/1986SE |
| K845035 | Electrode for Neurological Surgery 2111GYC · Traditional | 07/30/1985SN |
| K845036 | Tissue Expanders for Reconstruc-Surgery 3600LCJ · Traditional | 06/26/1985SE |
| K834047 | Pmt-Halo/Orthopedic Jacket SystemHAX · Traditional | 02/17/1984SE |
| K831329 | PMT Vaxiom Stereotactic Sys #FX001HAW · Traditional | 06/15/1983SE |
| K830530 | Temp TraceFLL · Traditional | 04/06/1983SE |
| K812744 | Levy Biotac #LX001 Biopsy Probe HolderHAW · Traditional | 12/03/1981SE |
| K810627 | Model 1301 Biotac (TM)GEA · Traditional | 04/02/1981SE |
Questions and answers
When was PMT 3721-1 Epidural Kit cleared by the FDA?
PMT 3721-1 Epidural Kit (K883314) received a 510(k) decision of Substantially Equivalent on October 28, 1988, 85 days after the submission was received.
What is the product code of K883314?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.