K971233 is an FDA 510(k) clearance for the SOFT TIP EPIDURAL CATHETER KIT. This device is classified as a Anesthesia Conduction Kit (Class II - Special Controls, product code CAZ).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 17, 1997, 198 days after receiving the submission on April 2, 1997.
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 | K971233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | April 02, 1997 |
| Decision Date | October 17, 1997 |
| Days to Decision | 198 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. |