K103658 is an FDA 510(k) clearance for the FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER. This device is classified as a Anesthesia Conduction Kit (Class II - Special Controls, product code CAZ).
Submitted by Teleflex, Inc. (Reading, US). The FDA issued a Cleared decision on May 16, 2012, 518 days after receiving the submission on December 15, 2010.
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 | K103658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2010 |
| Decision Date | May 16, 2012 |
| Days to Decision | 518 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. |