Arrow 0.2 Micron Flat Filter, GVS
FDA 510(k) K222341 · Arrow International, LLC
510(k) numberK222341
Submission
- Device name
- Arrow 0.2 Micron Flat Filter, GVS
- Applicant
- Arrow International, LLC
Morrisville, NC, US - Received
- August 3, 2022
- Decision date
- February 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
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| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
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More from Arrow International, Inc.
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| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | 05/27/2020SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | 04/09/2020SE |
| K190101 | UltraFlex IABDSP · Traditional | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | 06/13/2019SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | 03/31/2017SE |
| K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…MSD · Special | 07/07/2014SE |
| K130192 | Nextstep RetrogradeMSD · Traditional | 05/10/2013SESK |
| K130876 | Cg+ Arrow Picc Powered by Arrow VPS StyletLJS · Special | 04/26/2013SE |
Questions and answers
When was Arrow 0.2 Micron Flat Filter, GVS cleared by the FDA?
Arrow 0.2 Micron Flat Filter, GVS (K222341) received a 510(k) decision of Substantially Equivalent on February 13, 2023, 194 days after the submission was received.
What is the product code of K222341?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.