K945497 is an FDA 510(k) clearance for the B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT. This device is classified as a Anesthesia Conduction Kit (Class II - Special Controls, product code CAZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 13, 1995, 97 days after receiving the submission on November 8, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5140. 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..
| 510(k) Number | K945497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 08, 1994 |
| Decision Date | February 13, 1995 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAZ — Anesthesia Conduction Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5140 |
| Definition | 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. |