CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814— 510(k) K070288
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K070288 for CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814, Substantially Equivalent on 2007-06-18. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn Park, MN, US
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More clearances from Medtronic Vascular
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- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K192296 — Medtronic 6F Taiga Guiding Catheter
Adverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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.