FLEXCATH STEERABLE SHEATH & DILATOR— 510(k) K070357
Substantially EquivalentCryocath Technologies, Inc.
FDA 510(k) clearance K070357 for FLEXCATH STEERABLE SHEATH & DILATOR, Substantially Equivalent on 2007-12-28. Applicant: Cryocath Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Cryocath Technologies, Inc.
- 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
- Santa Fe, NM, 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
More clearances from Cryocath Technologies, Inc.
view all- K081049 — FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
- K062140 — SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
- K053436 — SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K040690 — SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K030303 — FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
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.