DXS

13 FDA 510(k) clearances · Product code

49 daysmedian time to decision

91 days90th percentile

13clearances measured

FDA profile

Official device name: Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4310
Medical specialty: Cardiovascular
Flags: Third-party review eligible
Adverse events (MAUDE): 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (K113235)	Medtronic, Inc.	2011-12-02
VTI DISPOSABLE PRESSURE DISPLAY SET (K944764)	Vascular Technology Incorporated	1994-12-27
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (K912045)	Lifestream Int'L, Inc.	1991-10-31
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (K900797)	Shiley, Inc.	1990-05-10
PRESSURE BARRIER KIT CAT. NO. PBK-3 (K873802)	American Omni Medical, Inc.	1987-11-06
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE (K862836)	Shiley, Inc.	1986-09-12
PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (K852232)	Dlp, Inc.	1985-08-09
PRESSURE MONITOR (K842194)	Norton Texas Medical Products	1984-08-27
PM-3 (K831750)	Delta Medical Industries	1983-07-26
GAMBRO PRESSURE MONITOR PRM 10 (K822822)	Gambro, Inc.	1982-10-18
PMS-2 PRESSURE MONITOR SEPARATOR (K820912)	Delta Medical Industries	1982-05-18
CHAMBER, MC-1 DISPOSABLE PRESSURE (K781890)	Delta Medical Industries	1978-12-04
CORONARY PRESSURE PERFUSION PUMP (K771764)	3M Health Care, Sarns	1977-09-30

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Every clearance here is in the API, with alerts when new ones post.