B-D Durasafe Combined Spinal Epidural (Cse) Tray
FDA 510(k) K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK954953
Submission
- Device name
- B-D Durasafe Combined Spinal Epidural (Cse) Tray
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lake, NJ, US - Received
- October 30, 1995
- Decision date
- May 20, 1996
- Decision
- Unknown (SESK)
- 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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Questions and answers
When was B-D Durasafe Combined Spinal Epidural (Cse) Tray cleared by the FDA?
B-D Durasafe Combined Spinal Epidural (Cse) Tray (K954953) received a 510(k) decision of Unknown on May 20, 1996, 203 days after the submission was received.
What is the product code of K954953?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.