Pressure Infusion Cuff
FDA 510(k) K942933 · Circulatory Technology, Inc.
510(k) numberK942933
Submission
- Device name
- Pressure Infusion Cuff
- Applicant
- Circulatory Technology, Inc.
Oyster Bay, NY, US - Received
- June 22, 1994
- Decision date
- August 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K953290 | Olympus Automatic Surgical Irrigation PumpKZD · Traditional | Olympus America, Inc. | 10/07/1995SE |
| K951988 | PressurizerKZD · Traditional | Promedic, Inc. | 06/14/1995SE |
| K930012 | Kawasumi Laboratories K-CuffKZD · Traditional | Kawasumi Laboratories Co., Ltd. | 12/14/1993SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
| K904484 | Baxter Single Patient Use Pressure InfusorKZD · Traditional | Tecnadyne Scientific, Inc. | 10/26/1990SE |
More from Tecnadyne Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140321 | Initary Better Bladder-PediatricDTN · Special | 04/17/2014SE |
| K012942 | The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog…DTN · Traditional | 11/05/2001SE |
| K001822 | The V-BagDTN · Traditional | 07/07/2000SE |
| K981284 | Better-Bladder (BB)DTN · Traditional | 08/12/1998SE |
| K964205 | Better-TubingDWF · Traditional | 04/08/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | 05/23/1997SE |
| K961594 | Better-VenterDWF · Traditional | 09/05/1996SE |
| K941492 | Pressure Relief ValveMNJ · Traditional | 10/26/1994SE |
Questions and answers
When was Pressure Infusion Cuff cleared by the FDA?
Pressure Infusion Cuff (K942933) received a 510(k) decision of Substantially Equivalent on August 25, 1994, 64 days after the submission was received.
What is the product code of K942933?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.