Organon Arterial Blood Sampler
FDA 510(k) K801435 · Akzona, Inc.
510(k) numberK801435
Submission
- Device name
- Organon Arterial Blood Sampler
- Applicant
- Akzona, Inc.
Mchenry, IL, US - Received
- June 19, 1980
- Decision date
- July 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBT – Arterial Blood Sampling Kit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1100
- Specialty
- Anesthesiology
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.
Other 510(k)s with product code CBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071269 | Hemodraw Arterial Blood Sampling SystemCBT · Traditional | Smiths Medical Asd, Inc. | 08/01/2007SE |
| K070340 | Secure Arterial Blood Sampling SystemCBT · Traditional | Smiths Medical Asd, Inc. | 03/15/2007SE |
| K955663 | Abc In-Line Blood Sampling KitCBT · Traditional | Utah Medical Products, Inc. | 03/17/1997SE |
| K954015 | Abg Point Lok Needle Protection DeviceCBT · Traditional | Devon Industries, Inc. | 11/20/1995SE |
| K954035 | Acti-Flex Arterial Extension SetCBT · Traditional | R-Group Intl. | 09/25/1995SE |
| K950098 | Needle Safety CoverCBT · Traditional | Hammer-Plane, Inc. | 08/11/1995SE |
| K945719 | Aspir-Pulse(Tm) Arterial Blood Gas (Abg) SystemCBT · Traditional | Sherwood Medical Co. | 03/16/1995SESK |
| K944941 | Piston SyringeCBT · Traditional | Martell Medical Products, Inc. | 12/05/1994SE |
| K945485 | Abg Needle ProtectionCBT · Traditional | Devon Industries, Inc. | 11/29/1994SE |
| K940575 | Aspir-Pulse(Tm) Saf-T-VentCBT · Traditional | Sherwood Medical Co. | 03/22/1994SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K772119 | Time WatchFPK · Traditional | 11/14/1977SE |
Questions and answers
When was Organon Arterial Blood Sampler cleared by the FDA?
Organon Arterial Blood Sampler (K801435) received a 510(k) decision of Substantially Equivalent on July 18, 1980, 29 days after the submission was received.
What is the product code of K801435?
The FDA product code is CBT – Arterial Blood Sampling Kit, a Class I (low risk) device regulated under 21 CFR 868.1100.