Gas-Lyte 1CC and 3CC Arterial Blood Samplers
FDA 510(k) K902632 · Marquest Medical Products, Inc.
510(k) numberK902632
Submission
- Device name
- Gas-Lyte 1CC and 3CC Arterial Blood Samplers
- Applicant
- Marquest Medical Products, Inc.
Englewood, CO, US - Received
- June 14, 1990
- Decision date
- September 4, 1990
- 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 |
|---|---|---|
| K050066 | C-CO2 Colorimetric CO2 IndicatorCCK · Traditional | 03/01/2005SE |
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | 07/16/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | 01/14/1997SE |
| K962220 | Heated Wire Circuits for SCT 3000 Heated HumidifierBZE · Traditional | 01/14/1997SE |
| K961838 | Respirgard II, SpirogardCAH · Traditional | 10/18/1996SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | 10/18/1996SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | 02/01/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | 10/11/1990SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | 08/17/1990SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | 07/15/1988SE |
Questions and answers
When was Gas-Lyte 1CC and 3CC Arterial Blood Samplers cleared by the FDA?
Gas-Lyte 1CC and 3CC Arterial Blood Samplers (K902632) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 82 days after the submission was received.
What is the product code of K902632?
The FDA product code is CBT – Arterial Blood Sampling Kit, a Class I (low risk) device regulated under 21 CFR 868.1100.