Arrow Epidural Catheter Kit
FDA 510(k) K143581 · Teleflexmedical, Inc.
510(k) numberK143581
Submission
- Device name
- Arrow Epidural Catheter Kit
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- December 18, 2014
- Decision date
- June 26, 2015
- 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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| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
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| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | 05/08/2019SESK |
| K181852 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 10/12/2018SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | 08/02/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | 02/12/2018SE |
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Questions and answers
When was Arrow Epidural Catheter Kit cleared by the FDA?
Arrow Epidural Catheter Kit (K143581) received a 510(k) decision of Substantially Equivalent on June 26, 2015, 190 days after the submission was received.
What is the product code of K143581?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.