Capiox(R) Bubble Trap
FDA 510(k) K911632 · Terumo Medical Corp.
510(k) numberK911632
Submission
- Device name
- Capiox(R) Bubble Trap
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- April 11, 1991
- Decision date
- July 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K961598 | Els Automatic Tubing Clamp SystemKRL · Traditional | Rocky Mountain Research, Inc. | 10/29/1996SE |
| 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 |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | Shiley, Inc. | 02/03/1987SE |
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Questions and answers
When was Capiox(R) Bubble Trap cleared by the FDA?
Capiox(R) Bubble Trap (K911632) received a 510(k) decision of Substantially Equivalent on July 9, 1991, 89 days after the submission was received.
What is the product code of K911632?
The FDA product code is KRL – Detector, Bubble, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4205.