Arrow 0.2 Micron Flat Filter, GVS
FDA 510(k) clearance K222341 · decided 2023-02-13
Clearance details
- K-number
- K222341
- Device name
- Arrow 0.2 Micron Flat Filter, GVS
- Applicant
- Arrow International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-08-03
- Decision date
- 2023-02-13
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- CAZ
- Device class
- 2
- Regulation number
- 868.5140
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Epilor Syringe (K210983) | Becton, Dickinson and Company | 2022-05-19 |
| Plastic LOR Syringe (K201356) | Jiangsu Caina Medical Co.,Ltd | 2021-02-12 |
| E-Cath STIM acc. Tsui (K202699) | PAJUNK GmbH Medizintechnologie | 2020-12-29 |
| VPC (K190345) | PAJUNK GmbH Medizintechnologie | 2019-05-16 |
| Arrow Epidural Catheter Kit (K161075) | Teleflexmedical, Inc. | 2016-10-04 |
| ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652) | Teleflex, Inc. | 2016-06-21 |
| Arrow Epidural Catheter Kit (K143581) | Teleflexmedical, Inc. | 2015-06-26 |
| ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (K122690) | Arrow International, Inc. | 2012-12-21 |
| CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (K110053) | Smiths Medical Asd, Inc. | 2012-09-14 |
| ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (K122027) | Arrow International, Inc. | 2012-08-28 |
| PERIFUSE CATHETER (K121525) | Smiths Medical Asd, Inc. | 2012-08-02 |
| CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403) | Teleflex, Inc. | 2012-06-20 |
Recalls involving this device
No recalls on record reference this clearance.