FOX PLUS PTA CATHETER— 510(k) K040954
Substantially EquivalentAbbott Laboratories, Inc.
FDA 510(k) clearance K040954 for FOX PLUS PTA CATHETER, Substantially Equivalent on 2004-05-11. Applicant: Abbott Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories, 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
- Special
- Location
- Redwood City, CA, US
Recent devices under product code LIT
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- K061193 — CREATININE
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- K040761 — AXSYM CYCLOSPORINE
- K023062 — GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
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.