Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit
FDA 510(k) K110053 · Smiths Medical Asd, Inc.
Submission
- Device name
- Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit
- Applicant
- Smiths Medical Asd, Inc.
Keene, NH, US - Received
- January 7, 2011
- Decision date
- September 14, 2012
- 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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Questions and answers
When was Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit cleared by the FDA?
Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit (K110053) received a 510(k) decision of Substantially Equivalent on September 14, 2012, 616 days after the submission was received.
What is the product code of K110053?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.