TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT— 510(k) K080967
Substantially EquivalentCordis Neurovascular, Inc.
FDA 510(k) clearance K080967 for TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT, Substantially Equivalent on 2008-05-02. Applicant: Cordis Neurovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cordis Neurovascular, Inc.
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Lakes, FL, US
Recent devices under product code HCG
view allMore clearances from Cordis Neurovascular, Inc.
view all- K082324 — TRUFILL DCS SYRINGE
- 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
- K053197 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.