Submission Details
| 510(k) Number | K954035 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 28, 1995 |
| Decision Date | September 25, 1995 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
ACTI-FLEX ARTERIAL EXTENSION SET
Sep 1995
Decision
28d
Days
Class 1
Risk
About This 510(k) Submission
K954035 is an FDA 510(k) clearance for the ACTI-FLEX ARTERIAL EXTENSION SET, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on September 25, 1995, 28 days after receiving the submission on August 28, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.
Device Classification
| 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. |
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