Product code KRL— Cardiovascular
ARTERIAL BUBBLE TRAP K-20
- Classification name
- Detector, Bubble, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4205
- Advisory panel
- Cardiovascular
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code KRL
FDA has cleared devices under product code KRL between 1980 and 2011, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2009
- 2007
- 1996
- 1994
- 1993
- 1991
- 1987
- 1986
- 1984
- 1980
Top applicants under product code KRL
Recent clearances under product code KRL
- K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
- K090698 — CAPIOX BUBBLE TRAP WITH X-COATING
- K071231 — EDAC QUANTIFIER
- K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC)
- K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM
- K940651 — SARNS ULTRASONIC AIR SENSOR
- K935977 — SARNS AIR DETECTION SYSTEM
- K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
- K925541 — STOCKERT 1/4 BUBBLE SENSOR
- K911632 — CAPIOX(R) BUBBLE TRAP
- K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
- K861860 — COBE ACCESSORY INTERFACE MODULE (AIM)
- K842054 — COBE AEPS
- K803102 — ARTERIAL BUBBLE TRAP K-20
Data sourced from openFDA. This site is unofficial and independent of the FDA.