Continuous Epidural Anesthesia Tray
FDA 510(k) K945671 · Trinity Laboratories, Inc.
510(k) numberK945671
Submission
- Device name
- Continuous Epidural Anesthesia Tray
- Applicant
- Trinity Laboratories, Inc.
Salisbury, MD, US - Received
- November 18, 1994
- Decision date
- February 16, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|
| K981441 | Heart Cath Tray, Sterile, DisposableDQO · Traditional | 07/10/1998SE |
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| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | 08/01/1997SE |
| K970722 | Eye TrayKKX · Traditional | 03/31/1997SE |
| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
| K953070 | Woundfoam 4 X 4KMF · Traditional | 09/08/1995SE |
Questions and answers
When was Continuous Epidural Anesthesia Tray cleared by the FDA?
Continuous Epidural Anesthesia Tray (K945671) received a 510(k) decision of Unknown on February 16, 1995, 90 days after the submission was received.
What is the product code of K945671?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.