FDA Product Code
FDA Product Code KRL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4205
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | 2011-01-18 | Traditional | PDF ↗ |
| K090698 | CAPIOX BUBBLE TRAP WITH X-COATING | Terumo Cardiovascular Systems | 2009-06-08 | Traditional | PDF ↗ |
| K071231 | EDAC QUANTIFIER | Luna Innovations, Inc. | 2007-05-17 | Traditional | PDF ↗ |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K940651 | SARNS ULTRASONIC AIR SENSOR | 3M Health Care, Sarns | 1994-05-24 | Traditional | PDF ↗ |
| K935977 | SARNS AIR DETECTION SYSTEM | 3M Health Care, Sarns | 1994-02-04 | Traditional | PDF ↗ |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | Sorin Biomedica, Fiat, USA, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K911632 | CAPIOX(R) BUBBLE TRAP | Terumo Medical Corp. | 1991-07-09 | Traditional | PDF ↗ |
| K864619 | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR | Shiley, Inc. | 1987-02-03 | Traditional | PDF ↗ |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K842054 | COBE AEPS | Cobe Laboratories, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K803102 | ARTERIAL BUBBLE TRAP K-20 | Delta Medical Industries | 1980-12-22 | Traditional | PDF ↗ |
Product code KRL · Class II · Cardiovascular. Data: openFDA.