Els Automatic Tubing Clamp System
FDA 510(k) K961598 · Rocky Mountain Research, Inc.
510(k) numberK961598
Submission
- Device name
- Els Automatic Tubing Clamp System
- Applicant
- Rocky Mountain Research, Inc.
Salt Lake City, UT, US - Received
- April 9, 1996
- Decision date
- October 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRL – Detector, Bubble, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4205
- Specialty
- Cardiovascular
Other 510(k)s with product code KRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | Sorin Group Deutschland GmbH | 01/18/2011SE |
| K090698 | Capiox Bubble Trap with X-CoatingKRL · Traditional | Terumo Cardiovascular Systems | 06/08/2009SE |
| K071231 | Edac QuantifierKRL · Traditional | Luna Innovations, Inc. | 05/17/2007SE |
| K961364 | Automatic Tubing Clamp System (Atc)KRL · Traditional | Rocky Mountain Research, Inc. | 10/31/1996SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 3M Health Care, Sarns | 05/24/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 3M Health Care, Sarns | 02/04/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/02/1993SE |
| K911632 | Capiox(R) Bubble TrapKRL · Traditional | Terumo Medical Corp. | 07/09/1991SE |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | Shiley, Inc. | 02/03/1987SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992857 | Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070DTW · Traditional | 11/10/1999SE |
| K961364 | Automatic Tubing Clamp System (Atc)KRL · Traditional | 10/31/1996SE |
| K921993 | Els Automatic Tubing Clamp SystemFIG · Traditional | 01/05/1994SE |
| K914459 | Automatic Tubing ClampFIG · Traditional | 06/24/1992SE |
Questions and answers
When was Els Automatic Tubing Clamp System cleared by the FDA?
Els Automatic Tubing Clamp System (K961598) received a 510(k) decision of Substantially Equivalent on October 29, 1996, 203 days after the submission was received.
What is the product code of K961598?
The FDA product code is KRL – Detector, Bubble, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4205.