Tray, Arterial Blood Gas Sampling
FDA 510(k) K781857 · Jelco Laboratories
510(k) numberK781857
Submission
- Device name
- Tray, Arterial Blood Gas Sampling
- Applicant
- Jelco Laboratories
Mchenry, IL, US - Received
- November 6, 1978
- Decision date
- December 11, 1978
- 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 |
|---|---|---|
| K791918 | Jelco Winged Intravascular CatheterFOZ · Traditional | 10/02/1979SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | 09/12/1979SE |
| K790967 | Catheter Metal Hub/RadiopaqueFOZ · Traditional | 06/27/1979SE |
| K790968 | Catheter Metal Hub/NonradiopaqueFOZ · Traditional | 06/11/1979SE |
| K790471 | Jelco* Disc FILTER-0.2 MicronFPB · Traditional | 04/30/1979SE |
| K790186 | ProtectivstabilizerGBJ · Traditional | 02/26/1979SE |
| K790107 | Catheter Tubing ModificationDQO · Traditional | 02/01/1979SE |
| K790079 | Needle, Blood CollectingGAA · Traditional | 02/01/1979SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | 08/23/1978SE |
| K780519 | Filter TubeBSN · Traditional | 05/09/1978SE |
Questions and answers
When was Tray, Arterial Blood Gas Sampling cleared by the FDA?
Tray, Arterial Blood Gas Sampling (K781857) received a 510(k) decision of Substantially Equivalent on December 11, 1978, 35 days after the submission was received.
What is the product code of K781857?
The FDA product code is CBT – Arterial Blood Sampling Kit, a Class I (low risk) device regulated under 21 CFR 868.1100.