MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES— 510(k) K010511
Substantially EquivalentCordis Neurovascular, Inc.
FDA 510(k) clearance K010511 for MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES, Substantially Equivalent on 2001-03-01. Applicant: Cordis Neurovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cordis Neurovascular, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Lake, FL, US
Recent devices under product code DQX
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 DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.