510(k) K912043
K912043 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "ACCU-VENT(TM) WITH NEEDLE-PRO(TM)". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 5, 1991. The device falls under product code CBT (Arterial Blood Sampling Kit), a Class I device regulated under 21 CFR 868.1100. Concord/Portex has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- July 5, 1991
- Date Received
- May 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arterial Blood Sampling Kit
- Device Class
- Class I
- Regulation Number
- 868.1100
- Review Panel
- AN
- Submission Type
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.