RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER— 510(k) K123544
Substantially EquivalentEv3, Inc.
FDA 510(k) clearance K123544 for RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER, Substantially Equivalent on 2013-02-12. 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
view allMore clearances from Ev3, Inc.
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
- K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.