Product code DRA— Cardiovascular
CRI CYNOSAR CATHETER
- Advisory panel
- Cardiovascular
- Total cleared
- 41
Adverse events under product code DRA
product code DRA- Death
- 156
- Injury
- 3,133
- Malfunction
- 6,266
- Total
- 9,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DRA
- K250529 — Globe Introducer (601-01001)
- K233248 — FARADRIVE Steerable Sheath
- K232321 — FlexCath Contour Steerable Sheath
- K223824 — POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
- K221397 — MitraClip G4 Steerable Guide Catheter
- K221044 — AcQGuide® VUE Steerable Sheath
- K211100 — AcQGuide MAX Steerable Sheath
- K202620 — FlexCath Advance Steerable Sheath and Dilator
- K192422 — Steerable Introducer 12F
- K190167 — MitraClip G4 Steerable Guide Catheter
- K183174 — FlexCath Advance Steerable Sheath and Dilator
- K172394 — Steerable Guide Catheter
- K162925 — AcQGuide Steerable Sheath
- K160919 — Hansen Medical Magellan Robotic Catheter 9Fr
- K161985 — Steerable Guide Catheter
- K152310 — HeartLight Deflectable Sheath
- K153304 — Hansen Medical Magellan Robotic Catheter eKit
- K151463 — Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
- K133552 — MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
- K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
- K122275 — ARTISAN EXTEND CONTROL CATHETER
- K120086 — CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
- K112541 — Z FLEX-270TM STEERABLE SHEATH
- K112239 — STEERABLE GUIDE CATHETER
- K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
- K100789 — MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
- K093866 — EVALVE STEERABLE GUIDE CATHETER
- K091596 — EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
- K083793 — STEERABLE GUIDE CATHETER
- K081049 — FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
- K070357 — FLEXCATH STEERABLE SHEATH & DILATOR
- K052575 — LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
- K050472 — LYSUS INFUSION SYSTEM
- K040165 — REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
- K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
- K924227 — CRI CYNOSAR CATHETER
- K913940 — RESPONSE(TM) STEERABLE CATHETER
- K904785 — CRI CYNOSAR CATHETER
- K900320 — CRI CYNOSAR CATHETER
- K884337 — MICRO-GUIDE SYSTEM
- K834352 — ADULT VENT CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.