K071269 is an FDA 510(k) clearance for the HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM. This device is classified as a Arterial Blood Sampling Kit (Class I - General Controls, product code CBT).
Submitted by Smiths Medical Asd, Inc. (Dublin, US). The FDA issued a Cleared decision on August 1, 2007, 86 days after receiving the submission on May 7, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1100. 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 | K071269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2007 |
| Decision Date | August 01, 2007 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBT — Arterial Blood Sampling Kit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1100 |
| 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. |