Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System
FDA 510(k) K041158 · Atrion Medical Products, Inc.
Submission
- Device name
- Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System
- Applicant
- Atrion Medical Products, Inc.
Arab, AL, US - Received
- May 3, 2004
- Decision date
- June 16, 2004
- 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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More from Smiths Medical Asd, Inc.
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|---|---|---|
| K060643 | QL Locking SyringeMAV · Traditional | 07/12/2006SE |
| K043249 | Atrion Needlevise Large-Bore Sharps Securing DeviceFMI · Traditional | 05/25/2005SE |
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| K973633 | Atrion Medical Products Lacrimal Intubation SetOKS · Traditional | 01/16/1998SE |
| K973872 | Atrion Medical Coated Lacrimal Intubation SetOKS · Traditional | 01/08/1998SE |
| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | 10/10/1997SE |
| K971100 | Atrion Medical Autogenous Tissue CollectorEIA · Traditional | 05/23/1997SE |
Questions and answers
When was Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System cleared by the FDA?
Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System (K041158) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 44 days after the submission was received.
What is the product code of K041158?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.