EVERCROSS 0.035 OTW PTA DILATION CATHETER— 510(k) K103322
Substantially EquivalentEv3, Inc.
FDA 510(k) clearance K103322 for EVERCROSS 0.035 OTW PTA DILATION CATHETER, Substantially Equivalent on 2010-12-06. Applicant: Ev3, Inc.. Device class: 2.
Clearance details
- Applicant
- Ev3, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code LIT
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view all- K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
- 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 LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 K103322
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 K103322.
Data sourced from openFDA. This site is unofficial and independent of the FDA.