510(k) K864619
- Device
- CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
- Applicant
- SHILEY, INC.
- 510(k) number
- K864619
- Product code
- KRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-03
- Date received
- 1986-11-24
- Regulation
- 870.4205
- Classification name
- Detector, Bubble, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MORTON BARAK
- Address
- 17600 Gillette Ave. P.O. Box 19503 Irvine CA US 92714 92714
FDA Registration Numbers#
- 9611109
- 1928237
- 8010026
- 1828100
- 3008307705
- 1649914
- 9681834
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | 2011-01-18 |
| K090698 | CAPIOX BUBBLE TRAP WITH X-COATING | Terumo Cardiovascular Systems | 2009-06-08 |
| K071231 | EDAC QUANTIFIER | Luna Innovations, Inc. | 2007-05-17 |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | 1996-10-31 |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1996-10-29 |
| K940651 | SARNS ULTRASONIC AIR SENSOR | 3M Health Care, Sarns | 1994-05-24 |
| K935977 | SARNS AIR DETECTION SYSTEM | 3M Health Care, Sarns | 1994-02-04 |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | Sorin Biomedica, Fiat, USA, Inc. | 1993-05-18 |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-02 |
| K911632 | CAPIOX(R) BUBBLE TRAP | Terumo Medical Corp. | 1991-07-09 |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | 1986-07-18 |
| K842054 | COBE AEPS | Cobe Laboratories, Inc. | 1984-08-02 |
| K803102 | ARTERIAL BUBBLE TRAP K-20 | Delta Medical Industries | 1980-12-22 |
Legacy Summary#
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FDA Review#
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