HYPERTRANSIT INFUSION CATHETER— 510(k) K043538
Substantially EquivalentCordis Neurovascular, Inc.
FDA 510(k) clearance K043538 for HYPERTRANSIT INFUSION CATHETER, Substantially Equivalent on 2005-04-18. Applicant: Cordis Neurovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cordis Neurovascular, 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
- Traditional
- Location
- Miami Lake, FL, US
Recent devices under product code KRA
view allMore clearances from Cordis Neurovascular, Inc.
view all- K082324 — TRUFILL DCS SYRINGE
- K080967 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
- K071962 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
- K070279 — MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
- K063254 — THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
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.