19 Ga Plastic Reinforced Epidural Catheter
FDA 510(k) K001587 · Arrow Intl., Inc.
510(k) numberK001587
Submission
- Device name
- 19 Ga Plastic Reinforced Epidural Catheter
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- May 23, 2000
- Decision date
- July 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model:…LJS · Traditional | 08/27/2010SE |
| K093050 | Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520DQY · Special | 12/18/2009SE |
| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
| K071998 | Arrow Echogenic Introducer Needle ComponentFMI · Special | 09/26/2007SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | 07/17/2007SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | 05/06/2004SE |
| K040802 | Hemosonic 200HEMODYNAMIC MonitorDPN · Special | 04/28/2004SE |
Questions and answers
When was 19 Ga Plastic Reinforced Epidural Catheter cleared by the FDA?
19 Ga Plastic Reinforced Epidural Catheter (K001587) received a 510(k) decision of Substantially Equivalent on July 12, 2000, 50 days after the submission was received.
What is the product code of K001587?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.