CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM— 510(k) K120086
Substantially EquivalentCardiosolutions
FDA 510(k) clearance K120086 for CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM, Substantially Equivalent on 2012-04-24. Applicant: Cardiosolutions. Device class: 2.
Clearance details
- Applicant
- Cardiosolutions
- Product code
- Code DRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1280
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Bridgewater, MA, US
Recent devices under product code DRA
view all- K262165 — FARADRIVE Steerable Sheath (M004PF21M402)
- 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
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.