Blood Gas Kit (Non-Sterile) Reorder No. 0560
FDA 510(k) K930986 · Customed, Inc.
510(k) numberK930986
Submission
- Device name
- Blood Gas Kit (Non-Sterile) Reorder No. 0560
- Applicant
- Customed, Inc.
Fajardo, PR, US - Received
- February 25, 1993
- Decision date
- July 14, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K260116 | CustoMED ViewerLLZ · Traditional | 06/03/2026SE |
| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | 01/05/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | 12/04/1997SE |
| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | 10/04/1996SE |
| K962596 | Customed Blood Extraction KitGJE · Traditional | 09/27/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
Questions and answers
When was Blood Gas Kit (Non-Sterile) Reorder No. 0560 cleared by the FDA?
Blood Gas Kit (Non-Sterile) Reorder No. 0560 (K930986) received a 510(k) decision of Unknown on July 14, 1993, 139 days after the submission was received.
What is the product code of K930986?
The FDA product code is CBT – Arterial Blood Sampling Kit, a Class I (low risk) device regulated under 21 CFR 868.1100.