CAZ — Anesthesia Conduction Kit Class II
Classification Details
- Product Code
- CAZ
- Device Class
- Class II
- Regulation Number
- 868.5140
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222341 | arrow international | Arrow 0.2 Micron Flat Filter, GVS | February 13, 2023 |
| K210983 | becton, dickinson and | BD Epilor Syringe | May 19, 2022 |
| K201356 | jiangsu caina medical co | Plastic LOR Syringe | February 12, 2021 |
| K202699 | pajunk gmbh medizintechnologie | E-Cath STIM acc. Tsui | December 29, 2020 |
| K190345 | pajunk gmbh medizintechnologie | VPC | May 16, 2019 |
| K161075 | teleflexmedical | Arrow Epidural Catheter Kit | October 4, 2016 |
| K153652 | teleflex | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | June 21, 2016 |
| K143581 | teleflexmedical | Arrow Epidural Catheter Kit | June 26, 2015 |
| K122690 | arrow international | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | December 21, 2012 |
| K110053 | smiths medical asd | CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN | September 14, 2012 |
| K122027 | arrow international | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | August 28, 2012 |
| K121525 | smiths medical asd | PERIFUSE CATHETER | August 2, 2012 |
| K121403 | teleflex | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | June 20, 2012 |
| K103658 | teleflex | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | May 16, 2012 |
| K113662 | imd | FENESTRATED NERVE BLOCK NEEDLE | April 20, 2012 |
| K113188 | pajunk gmbh medizintechnologie | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG | March 1, 2012 |
| K113059 | b.braun medical | CONTIPLEX FX | January 24, 2012 |
| K111355 | life-tech | ECHOBRIGHT | September 16, 2011 |
| K102007 | life-tech | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | December 22, 2010 |
| K093662 | life-tech | ECHOBRIGHT | June 24, 2010 |