Needle Safety Cover
FDA 510(k) K950098 · Hammer-Plane, Inc.
510(k) numberK950098
Submission
- Device name
- Needle Safety Cover
- Applicant
- Hammer-Plane, Inc.
Simi Valley, CA, US - Received
- January 10, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
| K931873 | VacventCBT · Traditional | Steven Frank Mercereau | 12/30/1993SEKD |
More from Steven Frank Mercereau
| 510(k) | Device | Decision |
|---|---|---|
| K933781 | Anti-Disconnection MechanismCBH · Traditional | 09/22/1993SE |
Questions and answers
When was Needle Safety Cover cleared by the FDA?
Needle Safety Cover (K950098) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 213 days after the submission was received.
What is the product code of K950098?
The FDA product code is CBT – Arterial Blood Sampling Kit, a Class I (low risk) device regulated under 21 CFR 868.1100.