Z FLEX-270TM STEERABLE SHEATH— 510(k) K112541
Substantially EquivalentGreat Batch Medical
FDA 510(k) clearance K112541 for Z FLEX-270TM STEERABLE SHEATH, Substantially Equivalent on 2012-02-07. Applicant: Great Batch Medical. Device class: 2.
Clearance details
- Applicant
- Great Batch Medical
- 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
- Plymouth, MN, US
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- 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 Great Batch Medical
view allAdverse 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 →
Recalls naming K112541
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112541.
Data sourced from openFDA. This site is unofficial and independent of the FDA.