KRL — Detector, Bubble, Cardiopulmonary Bypass Class II
FDA product code KRL covers "Detector, Bubble, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4205. Submissions are reviewed by the Cardiovascular panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRL
- Device Class
- Class II
- Regulation Number
- 870.4205
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K103469 | sorin group deutschland | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | January 18, 2011 |
| K090698 | terumo cardiovascular systems | CAPIOX BUBBLE TRAP WITH X-COATING | June 8, 2009 |
| K071231 | luna innovations | EDAC QUANTIFIER | May 17, 2007 |
| K961364 | rocky mountain research | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | October 31, 1996 |
| K961598 | rocky mountain research | ELS AUTOMATIC TUBING CLAMP SYSTEM | October 29, 1996 |
| K940651 | 3m health care, sarns | SARNS ULTRASONIC AIR SENSOR | May 24, 1994 |
| K935977 | 3m health care, sarns | SARNS AIR DETECTION SYSTEM | February 4, 1994 |
| K925661 | sorin biomedica, fiat, usa | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | May 18, 1993 |
| K925541 | sorin biomedica, fiat, usa | STOCKERT 1/4 BUBBLE SENSOR | February 2, 1993 |
| K911632 | terumo medical | CAPIOX(R) BUBBLE TRAP | July 9, 1991 |
| K864619 | shiley | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR | February 3, 1987 |
| K861860 | cobe laboratories | COBE ACCESSORY INTERFACE MODULE (AIM) | July 18, 1986 |
| K842054 | cobe laboratories | COBE AEPS | August 2, 1984 |
| K803102 | delta medical industries | ARTERIAL BUBBLE TRAP K-20 | December 22, 1980 |