MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS— 510(k) K111490
Substantially EquivalentEv3, Inc.
FDA 510(k) clearance K111490 for MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS, Substantially Equivalent on 2011-09-16. Applicant: Ev3, Inc.. Device class: 2.
Clearance details
- Applicant
- Ev3, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Menlo Park, CA, US
Recent devices under product code KRA
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- K132777 — NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
- K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
- K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE
Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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.